Europe Withdrawn Literature (English)

This webpage provides access to prior revisions of Directions for Use and product manuals for products sold in the European Union where this literature was exclusively provided electronically after 01 March, 2013.

  • NOTE: Prior Revision documents are watermarked and provided for REFERENCE ONLY.
  • If no documents are listed below, that means none exist at this time for the given filter selections.
  • ACURATE neo2™

    Patient Information

    Heart Valve

    Jan 08, 2024

    Product Code SYM-AC-010; SYM-DS-010; SYM-SV23-004; SYM-SV25-004; SYM-SV27-004

    Part Number 51213905-01A

  • ACURATE neo2™

    Instructions for Use

    Aortic Valve; Válvula aórtica; Valvule aortique; Válvula Aórtica Aortic Valve; Válvula aórtica; Valvule aortique; Válvula Aórtica

    Jan 08, 2024

    Product Code SYM-AC-010; SYM-DS-010; SYM-SV23-004; SYM-SV25-004; SYM-SV27-004

    Part Number 51081293-01A

    Safety Related Revision Blank

  • Q-TECH™ PROGRAMMER;EMBLEM™ S-ICD

    Programming Manuals

    PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHED; Q-TECH™ PROGRAMMIERGERÄT; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMMATEUR Q-TECH™; PROGRAMMATORE Q-TECH™; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHET

    Dec 01, 2011

    Product Code 2020

    Part Number 102099-110

    Applicable To SOUČÁST SYSTÉMU S-ICD®; EN DEL AF S-ICD®-SYSTEMET; EIN BESTANDTEIL DES S-ICD® SYSTEMS; A Component of the S-ICD® System; UN COMPONENTE DEL SISTEMA S-ICD®; COMPOSANT DU SYSTÈME S-ICD®; COMPONENTE DEL SISTEMA S-ICD®; EEN COMPONENT VAN HET S-ICD®-SYSTEEM; UM COMPONENTE DO SISTEMA S-ICD®; SÚČASŤ SYSTÉMU S-ICD®; EN KOMPONENT I S-ICD®-SYSTEMET

  • LATITUDE™

    Integration Guides

    LATITUDE™ Patient Management System

    Mar 31, 2014

    Product Code 6624

    Part Number 350011-008

    Applicable To INTEGRATION HL7 SPECIFICATION

  • RELIANCE™ 4-FRONT

    Instructions for Use

    Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors Tined Fixation

    Jul 14, 2022

    Product Code 0654; 0682; 0683; 0655; 0685; 0686; 0650; 0662;0663;0651; 0636; 0665

    Part Number 350063-081

    Safety Related Revision No

  • LATITUDE™ Programming System

    Programming Manuals

    Programmer

    Apr 22, 2022

    Product Code 3300

    Part Number 359488-058

    Safety Related Revision No

  • EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

    Instructions for Use

    Subcutaneous Implantable Cardioverter Defibrillator

    Sep 01, 2014

    Product Code A209

    Part Number 359279-001

  • INGEVITY™ MRI

    Instructions for Use

    Cardiac Lead

    Feb 01, 2017

    Product Code 7740; 7741; 7742

    Part Number 358659-059

    Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Extendable/Retractable Fixation

    Safety Related Revision No

  • VISIONIST™;VISIONIST™ X4;VALITUDE™;VALITUDE™ X4;INLIVEN™;INTUA™;INVIVE™

    Instructions for Use

    CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

    Oct 06, 2014

    Product Code U225; U226; U228; U125; U128; W274; W275; W272; W273; W172; W173

    Part Number 359254-001

  • INGEVITY™ MRI

    Instructions for Use

    Cardiac Lead

    May 01, 2018

    Product Code 7731; 7732; 7735; 7736

    Part Number 358661-040

    Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Tined Fixation; Pace/Sense Lead IS-1 Bipolar Connector Tined Fixation

    Safety Related Revision No

  • LATITUDE™ Programming System;LATITUDE™ Communicator;PERCIVA™ HF ICD;RESONATE™ HF ICD;RESONATE™ HF CRT-D;MOMENTUM™ EL ICD VR;MOMENTUM™ EL ICD DR;VIGILANT™ EL ICD;VIGILANT™ EL ICD;CHARISMA™ EL ICD VR;CHARISMA™ EL ICD DR;PERCIVA™ ICD VR;PERCIVA™ ICD DR;RESONATE™ EL ICD VR;RESONATE™ EL ICD DR;MOMENTUM™ CRT-D;MOMENTUM™ X4 CRT-D;VIGILANT™ CRT-D;VIGILANT™ X4 CRT-D;CHARISMA™ CRT-D;CHARISMA™ X4 CRT-D;RESONATE™ CRT-D;RESONATE™ X4 CRT-D

    Instructions for Use

    Sep 01, 2016

    Product Code 6290, D500, D501, D512, D513, D520, D521, D532, D533, G524, G525, G526, G528, G537, G547, G548, D120, D121, D220, D221, D232, D233, D320, D321, D332, D333, D400, D401, D412, D413, D420, D421, D432, D433, G124, G125, G126, G128, G138, G224, G225, G228,G237 G247, G248, G324, G325, G328, G337, G347, G348, G424, G425, G426, G428, G437, G447, G448

    Part Number 360206-001

  • EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

    Instructions for Use

    Subcutaneous Electrode

    Sep 01, 2015

    Product Code 3401

    Part Number 359469-001

    Safety Related Revision No

  • LATITUDE™ Programming System

    Programming Manuals

    Network and Connectivity

    Feb 01, 2018

    Product Code 3300; 3924

    Part Number 360166-020

    Applicable To Application for use with the LATITUDE™ Programming System

    Safety Related Revision No

  • AUTOGEN™ EL ICD;AUTOGEN™ MINI ICD;DYNAGEN™ EL ICD;DYNAGEN™ MINI ICD;INOGEN™ EL ICD;INOGEN™ MINI ICD;ORIGEN™ EL ICD;ORIGEN™ MINI ICD;INCEPTA™ ICD;ENERGEN™ ICD;PUNCTUA™ ICD;PUNCTUA™ NE ICD;TELIGEN™ 100 ICD

    Reference Guides

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    Feb 01, 2015

    Product Code D174; D175; D176; D177; D044; D045; D046; D047; D150; D151 ; D152; D153; D020; D021; D022; D023; D140; D141; D142; D143; D010; D011; D012; D013; D050; D051; D052; D053; D000; D001; D002; D003; F160; F161; F162; F163; F140; F141; F142; F143; F050; F051; F052; F053; F102; F103; F110; F111

    Part Number 359408-001

    Safety Related Revision No

  • LATITUDE™

    Clinician Manuals;Integration Guides

    LATITUDE NXT Patient Management System

    Aug 01, 2016

    Product Code 6624; 6455

    Part Number 359483-012

    Applicable To LATITUDE™ NXT - LATITUDE INTEGRATION IDCO AND HL7 SPECIFICATIONS

    Safety Related Revision No

  • AUTOGEN™ EL ICD;AUTOGEN™ MINI ICD;DYNAGEN™ EL ICD;DYNAGEN™ MINI ICD;INOGEN™ EL ICD;INOGEN™ MINI ICD;ORIGEN™ EL ICD;ORIGEN™ MINI ICD;INCEPTA™ ICD;ENERGEN™ ICD;PUNCTUA™ ICD;PUNCTUA™ NE ICD;TELIGEN™ 100 ICD

    Instructions for Use

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    Feb 01, 2015

    Product Code D174; D175; D176; D177; D044; D045; D046; D047; D150; D151 ; D152; D153; D020; D021; D022; D023; D140; D141; D142; D143; D010; D011; D012; D013; D050; D051; D052; D053; D000; D001; D002; D003; F160; F161; F162; F163; F140; F141; F142; F143; F050; F051; F052; F053; F102; F103; F110; F111

    Part Number 359404-001

    Safety Related Revision No

  • INVIVE™;VALITUDE™;VALITUDE™ X4;INTUA™;VISIONIST™ X4;VISIONIST™

    Patient Information

    Cardiac Resynchronization Therapy

    Feb 15, 2024

    Product Code U225; U226; U228; U125; W272; W273; W172; W173; W274; W292

    Part Number 356396-052

    Safety Related Revision No

  • VALITUDE™;VISIONIST™ X4;INTUA™;INVIVE™;INLIVEN™;VALITUDE™ X4;VISIONIST™

    Reference Guides

    CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

    Jun 18, 2024

    Product Code U225; U226; U228; U125; U128; W272; W273; W172; W173; W274; W275

    Part Number 359244-033

    Safety Related Revision Yes

  • PUNCTUA™ ICD;PUNCTUA™ NE ICD;ENERGEN™ ICD;INCEPTA™ ICD

    Instructions for Use

    IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATOR

    Nov 09, 2012

    Product Code F050; F051; F052; F053; F140; F141; F142; F143; F160; F161; F162; F163

    Part Number 358363-033

    Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

  • ACCOLADE™;FORMIO™;VITALIO™;INGENIO™;FORMIO™ MRI;ALTRUA™ 2;ADVANTIO™ MRI;INGENIO™ MRI;ACCOLADE™ MRI;ESSENTIO™;PROPONENT™ MRI;VITALIO™ MRI;ADVANTIO™;ESSENTIO™ MRI;PROPONENT™

    Instructions for Use

    Pacemaker

    Jun 18, 2024

    Product Code L300; L301; L321; L310; L311; L331; L200; L201; L209; L221; L210; L211; L231; L100; L101; L121; L110; L111; L131; S701; S702; S722; J278; J279; J272; J273; J274; J275; J276; J277; J172; J173; J174; J175; J176; J177; J062; J063; J064; J065; J067

    Part Number 359250-037

    Safety Related Revision Yes

  • AUTOGEN™ EL ICD;AUTOGEN™ MINI ICD;DYNAGEN™ EL ICD;DYNAGEN™ MINI ICD;INOGEN™ EL ICD;INOGEN™ MINI ICD;ORIGEN™ EL ICD;ORIGEN™ MINI ICD;INCEPTA™ ICD;ENERGEN™ ICD;PUNCTUA™ ICD;PUNCTUA™ NE ICD;TELIGEN™ 100 ICD

    Reference Guides

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    Nov 01, 2017

    Product Code D174; D175; D176; D177; D044; D045; D046; D047; D150; D151; D152; D153; D020; D021; D022; D023; D140; D141; D142; D143; D010; D011; D012; D013; D050; D051; D052; D053; D000; D001; D002; D003; F160; F161; F162; F163; F140; F141; F142; F143; F050; F051; F052; F053; F102; F103; F110; F111

    Part Number 359408-033

    Safety Related Revision No

  • PUNCTUA™ CRT-D;PUNCTUA™ NE CRT-D

    Reference Guides

    CARDIAC RESYNCHRONIZATION THERAPY HIGH ENERGY DEFIBRILLATOR

    Nov 13, 2012

    Product Code P052; P053

    Part Number 358370-018

    Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

  • EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

    Instructions for Use

    SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    Jul 07, 2021

    Product Code A209; A219

    Part Number 359481-055

    Safety Related Revision No

  • ZOOM™ LATITUDE™

    Programming Manuals

    Programmer/Recorder/Monitor

    Feb 28, 2014

    Product Code 3120

    Part Number 357435-130

  • RESONATE™ HF ICD;RESONATE™ EL ICD;PERCIVA™ HF ICD;PERCIVA™ ICD;CHARISMA™ EL ICD;VIGILANT™ EL ICD;MOMENTUM™ EL ICD

    Reference Guides

    Apr 01, 2017

    Product Code D520, D521, D532, D533, D420, D421, D432, D433, D500, D501, D512, D513 , D400, D401, D412, D413, D320, D321, D332, D333, D220, D221, D232, D233, D120, D121

    Part Number 360202-017

    Safety Related Revision No

  • EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

    Instructions for Use

    Instrument til indføring af subkutan elektrode; Einführhilfe für subkutane Elektrode; Subcutaneous Electrode Insertion Tool; Outil d’insertion d’électrode sous-cutanée; Tunnellizzatore sottocutaneo; Subcutane elektrode insertie tool; Subkutant elektrodeinnføringsverktøy; Införingsverktyg för subkutan elektrod

    Jun 02, 2014

    Product Code 4711

    Part Number 359316-001

  • VISIONIST™;VISIONIST™ X4;VALITUDE™;VALITUDE™ X4;INLIVEN™;INTUA™;INVIVE™

    Instructions for Use

    CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

    Mar 01, 2018

    Product Code U225; U226; U228; U125; U128; W272; W273; W172; W173; W274; W275

    Part Number 359254-035

    Safety Related Revision Yes

  • LATITUDE™ Programming System

    Programming Manuals

    Patient Data Management

    Mar 01, 2017

    Product Code 3300; 3931

    Part Number 360194-001

    Applicable To Application for use with the LATITUDE™ Programming System

  • ACCOLADE™;FORMIO™;VITALIO™;FORMIO™ MRI;INGENIO™;ALTRUA™ 2;ADVANTIO™ MRI;ACCOLADE™ MRI;ESSENTIO™;INGENIO™ MRI;PROPONENT™ MRI;VITALIO™ MRI;ADVANTIO™;ESSENTIO™ MRI;PROPONENT™

    Reference Guides

    PACEMAKER

    Feb 15, 2024

    Product Code L300; L301; L321; L310; L311; L331; L200; L201; L209; L221; L210; L211; L231; L100; L101; L121; L110; L111; L131; S701; S702; S722; J278; J279; J272; J273; J274; J275; J276; J277; J172; J173; J174; J175; J176; J177; J178; J062; J063; J064; J065; J066; J067

    Part Number 359241-033

    Safety Related Revision Yes

  • EMBLEM™ S-ICD

    Instructions for Use

    Automated Screening Tool (AST)

    Jan 13, 2021

    Product Code 2889

    Part Number 360195-001

    Safety Related Revision No

  • ACUITY™ X4 Spiral L;ACUITY™ X4 Spiral S;ACUITY™ X4 Straight;AUTOGEN™ X4 CRT-D;AUTOGEN™ EL ICD;DYNAGEN™ X4 CRT-D;DYNAGEN™ EL ICD;ENDOTAK RELIANCE™;FINELINE™ II;INGEVITY™ MRI;INOGEN™ EL ICD;INOGEN™ MINI ICD;INOGEN™ X4 CRT-D;ORIGEN™ EL ICD;ORIGEN™ MINI ICD;ORIGEN™ X4 CRT-D;RELIANCE™ 4-FRONT;RESONATE™ CRT-D

    MRI Information

    Defibrillator

    Aug 01, 2016

    Product Code D000; D002; D010; D012; D020; D022; D044; D046; D050; D052; D140; D142; D150; D152; D174; D176; G058; G148; G158; G179; 0262; 0263; 0265; 0266; 0272; 0273; 0275; 0276; 0282; 0283; 0285; 0286; 0292; 0293; 0295; 0296; 0636; 0650; 0651; 0652; 0653; 0654; 0655; 0657; 0658; 0662; 0663; 0665; 0672; 0673; 0675; 0676; 0682; 0683; 0685; 0686; 0692; 0693; 0695; 0696; 4469; 4470; 4471; 4472; 4473; 4474; 4479; 4480; 4603; 4671; 4672; 4674; 4675; 4677; 4678; 6220; 6221; 6402; 6403; 7145; 7735; 7736; 7740; 7741; 7742

    Part Number 359447-038

    Applicable To IMAGEREADY™

    Safety Related Revision No

  • 3300 LATITUDE™ Programming System

    Programming Manuals

    LATITUDE™ Programming System

    Jul 31, 2023

    Product Code 3300; 00802526618505; 3300; 00802526620003; 3300; 00802526618512; 3300; 00802526620331; 3154; 00802526586613; 6629; 00802526474071; 3889; 00802526613920

    Part Number 92362142-027

    Safety Related Revision No

  • ACUITY™ X4 Spiral L;ACUITY™ X4 Spiral S;ACUITY™ X4 Straight

    Instructions for Use

    Cardiac Lead

    Jan 01, 2018

    Product Code 4671; 4672; 4674; 4675; 4677; 4678

    Part Number 92035847-019

    Safety Related Revision No

  • AUTOGEN™ CRT-D;AUTOGEN™ X4 CRT-D;DYNAGEN™ CRT-D;DYNAGEN™ X4 CRT-D;INOGEN™ CRT-D;INOGEN™ X4 CRT-D;ORIGEN™ CRT-D;ORIGEN™ X4 CRT-D;INCEPTA™ CRT-D;ENERGEN™ CRT-D;PUNCTUA™ CRT-D;COGNIS™ 100-D CRT-D

    Instructions for Use

    CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

    Nov 01, 2017

    Product Code G172; G173;G175; G177; G179; G150; G151; G156; G158; G140; G141; G146; G148; G050; G051; G056; G58; P162; P163; P165; P142; P143; P052; P053; P106; P107; P108

    Part Number 359402-036

    Safety Related Revision No

  • DYNAGEN™ X4 CRT-D;VIGILANT™ EL ICD;INOGEN™ CRT-D;INGEVITY™ MRI;AUTOGEN™ MINI ICD;VIGILANT™ X4 CRT-D;CHARISMA™ EL ICD;ORIGEN™ CRT-D;INOGEN™ MINI ICD;AUTOGEN™ X4 CRT-D;RESONATE™ HF ICD;ACUITY™ Spiral;ENDOTAK RELIANCE™;AUTOGEN™ CRT-D;MOMENTUM™ EL ICD;DYNAGEN™ CRT-D;RESONATE™ EL ICD;ORIGEN™ MINI ICD;VIGILANT™ CRT-D;EASYTRAK™ 2;INOGEN™ EL ICD;ORIGEN™ EL ICD;RELIANCE™ 4-FRONT;ACUITY™ X4 Spiral L;PERCIVA™ HF ICD;RESONATE™ HF CRT-D;DYNAGEN™ EL ICD;DYNAGEN™ MINI ICD;RESONATE™ X4 CRT-D;ACUITY™ X4 Straight;FINELINE™ II;ACUITY™ X4 Spiral S;MOMENTUM™ X4 CRT-D;INOGEN™ X4 CRT-D;PERCIVA™ ICD;ORIGEN™ X4 CRT-D;RESONATE™ CRT-D;CHARISMA™ CRT-D;AUTOGEN™ EL ICD;MOMENTUM™ CRT-D;CHARISMA™ X4 CRT-D

    MRI Information

    Defibrillator

    Nov 01, 2017

    Product Code D000; D002; D010; D012; D020; D022; D044; D046; D050; D052; D140; D142; D150; D152; D174; D176; D232; D233; D332; D333; D412; D413; D432; D433; D512; D513; D532; D533; G058; G148; G158; G179; G237; G247; G337;G347; G437; G447; G537; G547; 0262; 0263; 0265; 0266; 0272; 0273; 0275; 0276; 0282; 0283; 0285; 0286; 0292; 0293; 0295; 0296; 0636; 0650; 0651; 0652; 0653; 0654; 0655; 0657; 0658; 0662; 0663; 0665; 0672; 0673; 0675; 0676; 0682; 0683; 0685; 0686; 0692; 0693; 0695; 0696; 4469; 4470; 4471; 4472; 4473; 4474; 4479; 4480; 4603; 4671; 4672; 4674; 4675; 4677; 4678; 6220; 6221; 6402; 6403; 7145; 7148; 7735; 7736; 7740; 7741; 7742

    Part Number 360205-019

    Applicable To IMAGEREADY™

    Safety Related Revision No

  • FINELINE™ II

    Instructions for Use

    Cardiac Lead

    Mar 01, 2015

    Product Code 4469; 4470; 4471; 4472; 4473; 4474

    Part Number 355405-242

    Applicable To FINELINE™ II STEROX EZ

    Safety Related Revision No

  • RESONATE™ HF CRT-D;RESONATE™ CRT-D;RESONATE™ X4 CRT-D;CHARISMA™ CRT-D;CHARISMA™ X4 CRT-D;VIGILANT™ CRT-D;VIGILANT™ X4 CRT-D;MOMENTUM™ CRT-D;MOMENTUM™ X4 CRT-D

    Reference Guides

    Apr 01, 2017

    Product Code G524, G525, G526, G528, G537, G547, G548, G424, G425, G426, G428, G437, G447, G448, G324, G325, G328, G337, G347, G348, G224, G225, G228, G237, G247, G248, G124, G125, G126, G128, G138

    Part Number 360201-017

    Safety Related Revision No

  • LATITUDE™

    Clinician Manuals

    LATITUDE NXT Patient Management System

    Aug 01, 2018

    Product Code 6446

    Part Number 358827-063

    Safety Related Revision No

  • LATITUDE™

    Integration Guides

    LATITUDE NXT Patient Management System

    Feb 01, 2015

    Product Code 6624

    Part Number 359273-021

    Applicable To LATITUDE INTEGRATION IDCO SPECIFICATION

    Safety Related Revision No

  • LATITUDE™

    Clinician Manuals

    LATITUDE™ NXT Patient Management System

    Oct 13, 2014

    Product Code 6446;6448

    Part Number 358827-010

  • LATITUDE™

    Integration Guides

    LATITUDE™ NXT Patient Management System

    May 01, 2014

    Product Code 6624

    Part Number 359273-011

    Applicable To LATITUDE INTEGRATION IDCO SPECIFICATION

    Safety Related Revision No

  • LATITUDE™

    Integration Guides

    LATITUDE™ Patient Management System

    Oct 13, 2013

    Product Code 6624

    Part Number 359273-001

    Applicable To LATITUDE INTEGRATION IDCO SPECIFICATION

  • COGNIS™ 100-D CRT-D;TELIGEN™ 100

    Instructions for Use;Supplemental Updates

    Defibrillator

    Jun 08, 2009

    Product Code F102; F103; F110; F111; P106; P107; P108

    Part Number 358201-001

    Applicable To Important Software Update Information (v1.05)

  • EMBLEM™ S-ICD Programmer

    Instructions for Use;Programming Manuals

    EMBLEM™ S-ICD Programmer

    Sep 14, 2022

    Product Code 3200

    Part Number 92346972-001

    Safety Related Revision No

  • AUTOGEN™ EL ICD;AUTOGEN™ MINI ICD;DYNAGEN™ EL ICD;DYNAGEN™ MINI ICD;INOGEN™ EL ICD;INOGEN™ MINI ICD;ORIGEN™ EL ICD;ORIGEN™ MINI ICD;INCEPTA™ ICD;ENERGEN™ ICD;PUNCTUA™ ICD;PUNCTUA™ NE ICD;TELIGEN™ 100 ICD

    Instructions for Use

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    Nov 01, 2017

    Product Code D174; D175; D176; D177; D044; D045; D046; D047; D150; D151; D152; D153; D020; D021; D022; D023; D140; D141; D142; D143; D010; D011; D012; D013; D050; D051; D052; D053; D000; D001; D002; D003; F160; F161; F162; F163; F140; F141; F142; F143; F050; F051; F052; F053; F102; F103; F110; F111

    Part Number 359404-041

    Safety Related Revision No

  • RELIANCE™ 4-FRONT

    Instructions for Use

    Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors Tined Fixation

    Mar 01, 2015

    Product Code 0654; 0682; 0683; 0655; 0685; 0686; 0650; 0662;0663;0651; 0636; 0665

    Part Number 350063-063

    Safety Related Revision No

  • LATITUDE™ Communicator

    Patient Information

    LATITUDE™ Communicator

    Mar 01, 2015

    Product Code 6288; 6290

    Part Number 359419-001

    Safety Related Revision No

  • INGEVITY™ MRI

    Instructions for Use

    Cardiac Lead

    May 01, 2018

    Product Code 7731; 7732; 7735; 7736

    Part Number 358661-076

    Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Tined Fixation

    Safety Related Revision No

  • LATITUDE Link™

    Integration Guides

    LATITUDE Link™ System

    Aug 01, 2014

    Product Code 6215; 6216

    Part Number 359384-001

    Applicable To IDCO SPECIFICATION

  • LATITUDE™ Programming System

    Programming Manuals

    Network and Connectivity

    Apr 22, 2022

    Product Code 3300; 3924

    Part Number 360166-039

    Applicable To Application for use with the LATITUDE™ Programming System

    Safety Related Revision No

  • EMBLEM™ S-ICD

    Patient Information

    SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    Jul 07, 2022

    Product Code A209; A219; 3501

    Part Number 92346920-001

    Applicable To N/A

    Applicable To N/A

    Safety Related Revision No

  • EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

    Programming Manuals

    EMBLEM™ S-ICD Programmer

    Sep 01, 2014

    Product Code 3200

    Part Number 359293-001

    Safety Related Revision No

  • EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

    Programming Manuals

    EMBLEM™ S-ICD Programmer

    Aug 01, 2017

    Product Code 3200

    Part Number 359465-033

    Safety Related Revision No

  • PUNCTUA™ CRT-D;PUNCTUA™ NE CRT-D;ENERGEN™ CRT-D;INCEPTA™ CRT-D

    Instructions for Use

    CARDIAC RESYNCHRONIZATION THERAPY HIGH ENERGY DEFIBRILLATOR

    Nov 09, 2012

    Product Code P052; P053; P142; P143; P162; P163; P165

    Part Number 358374-033

    Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

  • EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

    Instructions for Use

    Subkutan elektrode; Subkutane Elektrode; Subcutaneous Electrode; Électrode sous-cutanée; Elettrodo sottocutaneo; Subcutane elektrode; Subkutan elektrode; Subkutan elektrod

    Jun 01, 2014

    Product Code 3401

    Part Number 359315-001

  • AUTOGEN™ CRT-D;AUTOGEN™ X4 CRT-D;DYNAGEN™ CRT-D;DYNAGEN™ X4 CRT-D;INOGEN™ CRT-D;INOGEN™ X4 CRT-D;ORIGEN™ CRT-D;ORIGEN™ X4 CRT-D;INCEPTA™ CRT-D;ENERGEN™ CRT-D;PUNCTUA™ CRT-D;COGNIS™ 100-D CRT-D

    Reference Guides

    CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

    Nov 01, 2017

    Product Code G172; G173;G175; G177; G179; G150; G151; G156; G158; G140; G141; G146; G148; G050; G051; G056; G58; P162; P163; P165; P142; P143; P052; P053; P106; P107; P108

    Part Number 359406-035

    Safety Related Revision No

  • AUTOGEN™ EL ICD;AUTOGEN™ MINI ICD;DYNAGEN™ EL ICD;DYNAGEN™ MINI ICD;INOGEN™ EL ICD;INOGEN™ MINI ICD;ORIGEN™ EL ICD;ORIGEN™ MINI ICD;INCEPTA™ ICD;ENERGEN™ ICD;PUNCTUA™ ICD;PUNCTUA™ NE ICD;TELIGEN™ 100 ICD

    Instructions for Use

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    Nov 01, 2017

    Product Code D174; D175; D176; D177; D044; D045; D046; D047; D150; D151; D152; D153; D020; D021; D022; D023; D140; D141; D142; D143; D010; D011; D012; D013; D050; D051; D052; D053; D000; D001; D002; D003; F160; F161; F162; F163; F140; F141; F142; F143; F050; F051; F052; F053; F102; F103; F110; F111

    Part Number 359404-037

    Safety Related Revision No

  • RESONATE™ HF ICD;RESONATE™ EL ICD;PERCIVA™ HF ICD;PERCIVA™ ICD;CHARISMA™ EL ICD;VIGILANT™ EL ICD;MOMENTUM™ EL ICD

    Instructions for Use

    Apr 01, 2017

    Product Code D520, D521, D532, D533, D420, D421, D432, D433, D500, D501, D512, D513 , D400, D401, D412, D413, D320, D321, D332, D333, D220, D221, D232, D233, D120, D121

    Part Number 360204-019

  • AUTOGEN™ CRT-D;AUTOGEN™ X4 CRT-D;DYNAGEN™ CRT-D;DYNAGEN™ X4 CRT-D;INOGEN™ CRT-D;INOGEN™ X4 CRT-D;ORIGEN™ CRT-D;ORIGEN™ X4 CRT-D;INCEPTA™ CRT-D;ENERGEN™ CRT-D;PUNCTUA™ CRT-D;COGNIS™ 100-D CRT-D

    Reference Guides

    CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

    Feb 01, 2015

    Product Code G172; G173; G175; G177; G179; G150; G151; G156; G158; G140; G141; G146; G148; G050; G051; G056; G058; P162; P163; P165; P142; P143; P052; P053; P106; P107; P108

    Part Number 359406-001

    Safety Related Revision No

  • COGNIS™ 100-D CRT-D

    Instructions for Use

    CARDIAC RESYNCHRONIZATION THERAPY HIGH ENERGY DEFIBRILLATOR

    Oct 09, 2012

    Product Code P106; P107; P108

    Part Number 357485-094

    Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

  • VISIONIST™ X4;FORMIO™ MRI;ADVANTIO™ MRI;ACCOLADE™ MRI;INGENIO™ MRI;INGEVITY™ MRI;PROPONENT™ MRI;ACUITY™ X4 Spiral L;VITALIO™ MRI;ACUITY™ X4 Straight;FINELINE™ II;ACUITY™ X4 Spiral S;ESSENTIO™ MRI;VALITUDE™ X4

    MRI Information

    Pacemaker

    Dec 21, 2021

    Product Code J065; J066; J067; J175; J176; J177; J275; J276; J277; J279; L110; ;L111; L131; L210; L211; L231; L310; L311; L331; U128; U228; 4456; 4457; 4458; 4459; 4469; 4470; 4471; 4472; 4473;4474; 4479; 4480; 4603; 4671; 4672; 4674; 4675; 4676; 4677; 4678; 6220; 6221; 6402; 7145; 7148; 7731; 7732; 7735; 7736; 7740; 7741; 7742

    Part Number 359259-037

    Applicable To IMAGEREADY™

    Safety Related Revision Yes

  • LATITUDE™ Programming System

    Programming Manuals

    Programmer

    Mar 01, 2017

    Product Code 3300

    Part Number 359488-001

  • FINELINE™ II

    Instructions for Use

    Cardiac Lead

    Jun 21, 2022

    Product Code 4469; 4470; 4471; 4472; 4473; 4474

    Part Number 355405-242

    Applicable To FINELINE™ II STEROX EZ

    Safety Related Revision No

  • ACCOLADE™;ACCOLADE™ MRI;PROPONENT™;PROPONENT™ MRI;ESSENTIO™;ESSENTIO™ MRI;ALTRUA™ 2;FORMIO™;FORMIO™ MRI;VITALIO™;VITALIO™ MRI;INGENIO™;INGENIO™ MRI;ADVANTIO™;ADVANTIO™ MRI

    Reference Guides

    PACEMAKER

    Oct 06, 2014

    Product Code L300; L301; L321; L310; L311; L331; L200; L201; L209; L221; L210; L211; L231; L100; L101; L121; L110; L111; L131; S701; S702; S722; J278; J279; J272; J273; J274; J275; J276; J277; J172; J173; J174; J178; J175; J176; J177; J062; J063; J064; J065; J066; J067

    Part Number 359241-001

  • LATITUDE™

    Clinician Manuals

    LATITUDE™ NXT Patient Management System

    Mar 01, 2015

    Product Code 6446; 6448

    Part Number 358827-030

    Safety Related Revision No

  • INGEVITY™ MRI

    Instructions for Use

    Cardiac Lead

    Feb 01, 2017

    Product Code 7731; 7732; 7735; 7736

    Part Number 358661-058

    Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Tined Fixation

    Safety Related Revision No

  • CHARISMA™ EL ICD;CHARISMA™ CRT-D;FINELINE™ II Sterox;RESONATE™ CRT-D;RESONATE™ HF ICD;INOGEN™ MINI ICD;AUTOGEN™ MINI ICD;PERCIVA™ ICD;MOMENTUM™ CRT-D;DYNAGEN™ CRT-D;MOMENTUM™ EL ICD;AUTOGEN™ EL ICD;RESONATE™ X4 CRT-D;RESONATE™ HF CRT-D;CHARISMA™ X4 CRT-D;INGEVITY™ MRI;MOMENTUM™ X4 CRT-D;ORIGEN™ MINI ICD;ORIGEN™ EL ICD;ENDOTAK RELIANCE™;VIGILANT™ EL ICD;AUTOGEN™ X4 CRT-D;VIGILANT™ CRT-D;DYNAGEN™ EL ICD;EASYTRAK™ 2 IS-1;PERCIVA™ HF ICD;RELIANCE™ 4-FRONT;INOGEN™ CRT-D;FINELINE™ II Sterox EZ;INOGEN™ EL ICD;VIGILANT™ X4 CRT-D;INOGEN™ X4 CRT-D;EASYTRAK™ 2;DYNAGEN™ MINI ICD;RESONATE™ EL ICD;ACUITY™ X4 Spiral L;ORIGEN™ X4 CRT-D;AUTOGEN™ CRT-D;ACUITY™ X4 Straight;FINELINE™ II;ORIGEN™ CRT-D;ACUITY™ Spiral;ACUITY™ X4 Spiral S;DYNAGEN™ X4 CRT-D

    MRI Information

    IMAGEREADY™ MR Conditional Defibrillation System

    Dec 05, 2022

    Product Code D000; D001; D002; D003; D010; D011; D012; D013; D020; D021; D022; D023; D044; D045; D046; D047; D050; D051; D052; D053; D120; D121; D140; D141; D142; D143; D150; D151; D152; D153; D174; D175; D176; D177; D220; D221; D232; D233; D320; D321; D332; D333; D400; D401; D412; D413; D420; D421; D432; D433; D500; D501; D512; D513; D520; D521; D532; D533; G050; G051; G056; G058; G124; G125; G128; G138; G140; G141; G146; G148; G150; G151; G156; G158; G172; G173; G177; G179; G224; G225; G228; G237; G247; G248; G324; G325; G328; G337; G347; G348; G424; G425; G428; G437; G447; G448; G524; G525; G528; G537; G547; G548; 0127; 0128; 0129; 0137; 0138; 0139; 0143; 0147; 0148; 0149; 0153; 0157; 0158; 0159; 0170; 0171; 0172; 0173; 0174; 0175; 0176; 0177; 0180; 0181; 0182; 0183; 0184; 0185; 0186; 0187; 0262; 0263; 0265; 0266; 0272; 0273; 0275; 0276; 0282; 0283; 0285; 0286; 0292; 0293; 0295; 0296; 0636; 0650; 0651; 0652; 0653; 0654; 0655; 0657; 0658; 0662; 0663; 0665; 0672; 0673; 0675; 0676; 0682; 0683; 0685; 0686; 0692; 0693; 0695; 0696; 4469; 4470; 4471; 4472; 4473; 4474; 4479; 4480; 4542; 4543; 4544; 4591; 4592; 4593; 4603; 4671; 4672; 4674; 4675; 4677; 4678; 6100; 6220; 6221; 6402; 6403; 6773; 6996; 7145; 7148; 7735; 7736; 7740; 7741; 7742

    Part Number 51114107-001

    Applicable To IMAGEREADY™

    Safety Related Revision No

  • RESONATE™ HF CRT-D;RESONATE™ CRT-D;RESONATE™ X4 CRT-D;CHARISMA™ CRT-D;CHARISMA™ X4 CRT-D;VIGILANT™ CRT-D;VIGILANT™ X4 CRT-D;MOMENTUM™ CRT-D;MOMENTUM™ X4 CRT-D

    Instructions for Use

    Apr 01, 2017

    Product Code G524, G525, G526, G528, G537, G547, G548, G424, G425, G426, G428, G437, G447, G448, G324, G325, G328, G337, G347, G348, G224, G225, G228, G237, G247, G248, G124, G125, G126, G128, G138

    Part Number 360203-019

  • CHARISMA™ EL ICD;CHARISMA™ CRT-D;RESONATE™ HF ICD;RESONATE™ CRT-D;INOGEN™ MINI ICD;AUTOGEN™ MINI ICD;PERCIVA™ ICD;MOMENTUM™ CRT-D;MOMENTUM™ EL ICD;DYNAGEN™ CRT-D;AUTOGEN™ EL ICD;RESONATE™ HF CRT-D;RESONATE™ X4 CRT-D;CHARISMA™ X4 CRT-D;INGEVITY™ MRI;MOMENTUM™ X4 CRT-D;ORIGEN™ MINI ICD;ORIGEN™ EL ICD;VIGILANT™ EL ICD;ENDOTAK RELIANCE™;AUTOGEN™ X4 CRT-D;VIGILANT™ CRT-D;DYNAGEN™ EL ICD;PERCIVA™ HF ICD;RELIANCE™ 4-FRONT;INOGEN™ CRT-D;INOGEN™ EL ICD;VIGILANT™ X4 CRT-D;INOGEN™ X4 CRT-D;EASYTRAK™ 2;RESONATE™ EL ICD;DYNAGEN™ MINI ICD;ACUITY™ X4 Spiral L;ORIGEN™ X4 CRT-D;AUTOGEN™ CRT-D;ACUITY™ X4 Straight;FINELINE™ II;ORIGEN™ CRT-D;ACUITY™ Spiral;ACUITY™ X4 Spiral S;DYNAGEN™ X4 CRT-D

    MRI Information

    Defibrillator

    Oct 12, 2021

    Product Code D000; D002; D010; D012; D020; D022; D044; D046; D050; D052; D140; D142; D150; D152; D174; D176; D232; D233; D332; D333; D412; D413; D432; D433; D512; D513; D532; D533; G058; G148; G158; G179; G237; G247; G337;G347; G437; G447; G537; G547; 0262; 0263; 0265; 0266; 0272; 0273; 0275; 0276; 0282; 0283; 0285; 0286; 0292; 0293; 0295; 0296; 0636; 0650; 0651; 0652; 0653; 0654; 0655; 0657; 0658; 0662; 0663; 0665; 0672; 0673; 0675; 0676; 0682; 0683; 0685; 0686; 0692; 0693; 0695; 0696; 4469; 4470; 4471; 4472; 4473; 4474; 4479; 4480; 4603; 4671; 4672; 4674; 4675; 4677; 4678; 6220; 6221; 6402; 6403; 7145; 7148; 7735; 7736; 7740; 7741; 7742

    Part Number 360205-037

    Applicable To IMAGEREADY™

    Safety Related Revision No

  • INGEVITY™ MRI

    Instructions for Use

    Cardiac Lead

    Mar 02, 2015

    Product Code 7731; 7732; 7735; 7736

    Part Number 358661-040

    Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Tined Fixation; Pace/Sense Lead IS-1 Bipolar Connector Tined Fixation

    Safety Related Revision No

  • INGEVITY™ MRI

    Instructions for Use

    Cardiac Lead

    May 01, 2018

    Product Code 7740; 7741; 7742

    Part Number 358659-113

    Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Extendable/Retractable Fixation

    Safety Related Revision No

  • AUTOGEN™ CRT-D;AUTOGEN™ X4 CRT-D;DYNAGEN™ CRT-D;DYNAGEN™ X4 CRT-D;INOGEN™ CRT-D;INOGEN™ X4 CRT-D;ORIGEN™ CRT-D;ORIGEN™ X4 CRT-D;INCEPTA™ CRT-D;ENERGEN™ CRT-D;PUNCTUA™ CRT-D;COGNIS™ 100-D CRT-D

    Instructions for Use

    CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

    Feb 01, 2015

    Product Code G172; G173; G175; G177; G179; G150; G151; G156; G158; G140; G141; G146; G148; G050; G051; G056; G058; P162; P163; P165; P142; P143; P052; P053; P106; P107; P108

    Part Number 359402-001

    Safety Related Revision No

  • CHARISMA™ EL ICD;CHARISMA™ CRT-D;RESONATE™ CRT-D;RESONATE™ HF ICD;FINELINE™ II Sterox;INOGEN™ MINI ICD;AUTOGEN™ MINI ICD;PERCIVA™ ICD;MOMENTUM™ CRT-D;DYNAGEN™ CRT-D;MOMENTUM™ EL ICD;AUTOGEN™ EL ICD;RESONATE™ HF CRT-D;RESONATE™ X4 CRT-D;CHARISMA™ X4 CRT-D;MOMENTUM™ X4 CRT-D;INGEVITY™ MRI;ORIGEN™ MINI ICD;ENDOTAK RELIANCE™ SG;ORIGEN™ EL ICD;VIGILANT™ EL ICD;ENDOTAK RELIANCE™;AUTOGEN™ X4 CRT-D;VIGILANT™ CRT-D;DYNAGEN™ EL ICD;PERCIVA™ HF ICD;ENDOTAK RELIANCE™ S;EASYTRAK™ 2 IS-1;RELIANCE™ 4-FRONT;INGEVITY™+;INOGEN™ CRT-D;FINELINE™ II Sterox EZ;INOGEN™ EL ICD;VIGILANT™ X4 CRT-D;INOGEN™ X4 CRT-D;EASYTRAK™ 2;DYNAGEN™ MINI ICD;RESONATE™ EL ICD;ENDOTAK RELIANCE™ G;ORIGEN™ X4 CRT-D;ACUITY™ X4 Spiral L;AUTOGEN™ CRT-D;ACUITY™ X4 Straight;FINELINE™ II;ORIGEN™ CRT-D;ACUITY™ Spiral;ACUITY™ X4 Spiral S;DYNAGEN™ X4 CRT-D

    MRI Information

    IMAGEREADY™ MR Conditional Defibrillation System

    Sep 12, 2022

    Product Code D000; D001; D002; D003; D010; D011; D012; D013; D020; D021; D022; D023; D044; D045; D046; D047; D050; D051; D052; D053; D120; D121; D140; D141; D142; D143; D150; D151; D152; D153; D174; D175; D176; D177; D220; D221; D232; D233; D320; D321; D332; D333; D400; D401; D412; D413; D420; D421; D432; D433; D500; D501; D512; D513; D520; D521; D532; D533; G050; G051; G056; G058; G124; G125; G128; G138; G140; G141; G146; G148; G150; G151; G156; G158; G172; G173; G177; G179; G224; G225; G228; G237; G247; G248; G324; G325; G328; G337; G347; G348; G424; G425; G428; G437; G447; G448; G524; G525; G528; G537; G547; G548; 0127; 0128; 0129; 0137; 0138; 0139; 0143; 0147; 0148; 0149; 0153; 0157; 0158; 0159; 0170; 0171; 0172; 0173; 0174; 0175; 0176; 0177; 0180; 0181; 0182; 0183; 0184; 0185; 0186; 0187; 0262; 0263; 0265; 0266; 0272; 0273; 0275; 0276; 0282; 0283; 0285; 0286; 0292; 0293; 0295; 0296; 0636; 0650; 0651; 0652; 0653; 0654; 0655; 0657; 0658; 0662; 0663; 0665; 0672; 0673; 0675; 0676; 0682; 0683; 0685; 0686; 0692; 0693; 0695; 0696; 4469; 4470; 4471; 4472; 4473; 4474; 4479; 4480; 4542; 4543; 4544; 4591; 4592; 4593; 4603; 4671; 4672; 4674; 4675; 4677; 4678; 6100; 6220; 6221; 6402; 6403; 6773; 6996; 7145; 7148; 7735; 7736; 7740; 7741; 7742; 7840; 7841; 7842

    Part Number 51308710-001

    Applicable To IMAGEREADY™

  • ENDOTAK RELIANCE™

    Instructions for Use

    Cardiac Lead

    Mar 01, 2015

    Product Code 0295; 0296; 0292; 0293; 0275; 0276

    Part Number 358074-083

    Applicable To Pace/Sense and Defibrillation Lead; Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors; Extendable/Retractable Fixation

    Safety Related Revision No

  • INVIVE™;VALITUDE™;VALITUDE™ X4;INTUA™;VISIONIST™ X4;VISIONIST™

    Patient Information

    Cardiac Resynchronization Therapy

    Jan 01, 2018

    Product Code U225; U226; U228; U125; W272; W273; W172; W173; W274; W292

    Part Number 356396-052

    Safety Related Revision No

  • EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

    Programming Manuals

    EMBLEM™ S-ICD Programmer

    Jul 07, 2021

    Product Code 3200

    Part Number 359465-065

    Safety Related Revision No

  • EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

    Instructions for Use

    Subcutaneous Electrode Insertion Tool

    Sep 01, 2015

    Product Code 4711

    Part Number 359472-001

    Safety Related Revision No

  • TELIGEN™ 100

    Reference Guides

    IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATOR

    Nov 13, 2012

    Product Code F102; F103; F110; F111

    Part Number 357403-075

    Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

  • EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

    Instructions for Use

    Subcutaneous Electrode

    Jul 07, 2021

    Product Code 3501

    Part Number 360168-019

    Safety Related Revision No

  • EMBLEM™ S-ICD Electrode;Q-TRAK™ S-ICD Electrode;EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD;EMBLEM™ S-ICD Programmer

    MRI Information

    Subcutaneous Implantable Cardioverter Defibrillator; Subcutaneous Electrode

    Jul 07, 2021

    Product Code A209; A219; 3400; 3401; 3501

    Part Number 359475-019

    Applicable To IMAGEREADY™

    Safety Related Revision No

  • LATITUDE™ Programming System

    Programming Manuals

    Network and Connectivity

    Feb 01, 2017

    Product Code 3300; 3924

    Part Number 360166-001

    Applicable To Application for use with the LATITUDE™ Programming System

  • AUTOGEN™ EL ICD;AUTOGEN™ MINI ICD;DYNAGEN™ EL ICD;DYNAGEN™ MINI ICD;INOGEN™ EL ICD;INOGEN™ MINI ICD;ORIGEN™ EL ICD;ORIGEN™ MINI ICD;INCEPTA™ ICD;ENERGEN™ ICD;PUNCTUA™ ICD;PUNCTUA™ NE ICD;TELIGEN™ 100 ICD

    Reference Guides

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    Nov 01, 2017

    Product Code D174; D175; D176; D177; D044; D045; D046; D047; D150; D151; D152; D153; D020; D021; D022; D023; D140; D141; D142; D143; D010; D011; D012; D013; D050; D051; D052; D053; D000; D001; D002; D003; F160; F161; F162; F163; F140; F141; F142; F143; F050; F051; F052; F053; F102; F103; F110; F111

    Part Number 359408-035

    Safety Related Revision No

  • LATITUDE™ Communicator

    Patient Information

    LATITUDE™ Communicator

    May 20, 2022

    Product Code 6288; 6290

    Part Number 359419-020

    Safety Related Revision No

  • INGEVITY™ MRI

    Instructions for Use

    Cardiac Lead

    Dec 01, 2014

    Product Code 7731; 7732; 7735; 7736

    Part Number 358661-022

    Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Tined Fixation

    Safety Related Revision No

  • INGEVITY™

    Patient Information

    Pace/Sense Lead

    Feb 23, 2024

    Product Code 7731; 7732; 7735; 7736; 7740; 7741; 7742; 7840; 7841; 7842

    Part Number 50944538-028

    Applicable To N/A

    Applicable To N/A

  • ORIGEN™ MINI ICD;INOGEN™ MINI ICD;DYNAGEN™ MINI ICD VR;DYNAGEN™ MINI ICD DR;AUTOGEN™ MINI ICD VR;AUTOGEN™ MINI ICD DR;ORIGEN™ EL ICD;INOGEN™ EL ICD;INOGEN™ EL ICD;DYNAGEN™ EL ICD VR;DYNAGEN™ EL ICD DR;AUTOGEN™ EL ICD VR;AUTOGEN™ EL ICD DR;VIGILANT™ EL ICD;VIGILANT™ EL ICD;CHARISMA™ EL ICD VR;CHARISMA™ EL ICD DR;PERCIVA™ ICD VR;PERCIVA™ ICD DR;RESONATE™ EL ICD VR;RESONATE™ EL ICD DR;PERCIVA™ HF ICD;RESONATE™ HF ICD;ORIGEN™ X4 CRT-D;INOGEN™ X4 CRT-D;DYNAGEN™ X4 CRT-D;AUTOGEN™ X4 CRT-D;VIGILANT™ X4 CRT-D;CHARISMA™ X4 CRT-D;RESONATE™ X4 CRT-D;RESONATE™ HF CRT-D;ENDOTAK RELIANCE™;ENDOTAK RELIANCE™ S;ENDOTAK RELIANCE™ SG;ENDOTAK RELIANCE™ G;RELIANCE™ 4-FRONT;RELIANCE™ 4-FRONT;FINELINE™ II Sterox EZ;FINELINE™ II EZ Sterox;FINELINE™ II Sterox

    MRI Information

    IMAGEREADY™ MR CONDITIONAL DEFIBRILLATION SYSTEM

    Aug 01, 2016

    Product Code D000, D002, D010, D012, D020, D022, D044, D046, D050, D052, D140, D142, D150, D152, D174, D176, D232, D233, D332, D333, D412, D413, D432, D433, D512, D513, D532, D533, G058, G148, G158, G179, G237, G247, G337, G347, G437, G447, G537, G547, 0262, 0263, 0265, 0266, 0272, 0273, 0275, 0276, 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296, 0636, 0650, 0651, 0652, 0653, 0654, 0655, 0657, 0658, 0662, 0663, 0665, 0672, 0673, 0675, 0676, 0682, 0683, 0685, 0686, 0692, 0693, 0695, 0696, 4469, 4470, 4471, 4472, 4473, 4474, 4479, 4480, 4603, 4671, 4672, 4674, 4675, 4677, 4678, 6220, 6221, 6402, 6403, 7145, 7148, 7735, 7736, 7740, 7741, 7742

    Part Number 360205-001

  • ACCOLADE™;FORMIO™;VITALIO™;INGENIO™;FORMIO™ MRI;ALTRUA™ 2;ADVANTIO™ MRI;INGENIO™ MRI;ACCOLADE™ MRI;ESSENTIO™;PROPONENT™ MRI;VITALIO™ MRI;ADVANTIO™;ESSENTIO™ MRI;PROPONENT™

    Reference Guides

    PACEMAKER

    Jun 18, 2024

    Product Code L300; L301; L321; L310; L311; L331; L200; L201; L209; L221; L210; L211; L231; L100; L101; L121; L110; L111; L131; S701; S702; S722; J278; J279; J272; J273; J274; J275; J276; J277; J172; J173; J174; J175; J176; J177; J178; J062; J063; J064; J065; J066; J067

    Part Number 359241-033

    Safety Related Revision Yes

  • 3300 LATITUDE™ Programming System

    Programming Manuals

    Pacing System Analyzer (PSA)

    Jul 31, 2023

    Product Code 3922; 3300; 00802526618505; 3300; 00802526620003; 3300; 00802526618512; 3300; 00802526620331

    Part Number 92402515-001

    Applicable To Application for use with the LATITUDE™ Programming System

    Safety Related Revision No

  • EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

    Instructions for Use

    Electrode Delivery System

    Jul 07, 2021

    Product Code 4712

    Part Number 360210-001

  • ACUITY™ X4 Straight;ACUITY™ X4 Spiral S;ACUITY™ X4 Spiral L

    Instructions for Use

    Defibrillator

    Jan 01, 2018

    Product Code 4671, 4672, 4674, 4675, 4677, 4678

    Part Number 92035847-001

    Safety Related Revision No

  • INGEVITY™ MRI

    Instructions for Use

    Cardiac Lead

    Apr 04, 2024

    Product Code 7731; 7732; 7735; 7736

    Part Number 358661-112

    Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Tined Fixation

    Safety Related Revision No

  • RESONATE™ HF ICD;RESONATE™ EL ICD;PERCIVA™ HF ICD;PERCIVA™ ICD;CHARISMA™ EL ICD;VIGILANT™ EL ICD;MOMENTUM™ EL ICD

    Reference Guides

    Sep 01, 2016

    Product Code D520, D521, D532, D533, D420, D421, D432, D433, D500, D501, D512, D513 , D400, D401, D412, D413, D320, D321, D332, D333, D220, D221, D232, D233, D120, D121

    Part Number 360202-001

  • EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

    Instructions for Use

    Subcutaneous Electrode

    Nov 01, 2016

    Product Code 3501

    Part Number 360168-001

  • VISIONIST™;VISIONIST™ X4;VALITUDE™;VALITUDE™ X4;INLIVEN™;INTUA™;INVIVE™

    Reference Guides

    CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

    Oct 06, 2014

    Product Code U225; U226; U228; U125; U128; W274; W275; W272; W273; W172; W173

    Part Number 359244-001

  • INGEVITY™ MRI

    Instructions for Use

    Cardiac Lead

    May 02, 2018

    Product Code 7740; 7741; 7742

    Part Number 358659-077

    Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Extendable/Retractable Fixation

    Safety Related Revision No

  • EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

    Programming Manuals

    EMBLEM™ S-ICD Programmer

    Oct 01, 2018

    Product Code 3200

    Part Number 359465-049

    Safety Related Revision No

  • LATITUDE™

    Clinician Manuals

    LATITUDE NXT Patient Management System

    Oct 01, 2018

    Product Code 6446; 6447

    Part Number 358827-074

    Safety Related Revision No

  • AUTOGEN™ CRT-D;AUTOGEN™ X4 CRT-D;DYNAGEN™ CRT-D;DYNAGEN™ X4 CRT-D;INOGEN™ CRT-D;INOGEN™ X4 CRT-D;ORIGEN™ CRT-D;ORIGEN™ X4 CRT-D

    Reference Guides

    CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

    Nov 17, 2013

    Product Code G172; G173; G175; G177; G179; G150; G151; G156; G158; G140; G141; G146; G148; G050; G051; G056; G058

    Part Number 359209-001

  • EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

    Instructions for Use

    SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    Nov 01, 2016

    Product Code A209; A219

    Part Number 359481-019

    Safety Related Revision No

  • LATITUDE™

    Clinician Manuals

    LATITUDE NXT Patient Management System

    Jul 01, 2015

    Product Code 6446

    Part Number 358827-041

    Safety Related Revision No

  • ACCOLADE™;ACCOLADE™ MRI;PROPONENT™;PROPONENT™ MRI;ESSENTIO™;ESSENTIO™ MRI;ALTRUA™ 2;FORMIO™;FORMIO™ MRI;VITALIO™;VITALIO™ MRI;INGENIO™;INGENIO™ MRI;ADVANTIO™;ADVANTIO™ MRI

    Instructions for Use

    Pacemaker

    Mar 01, 2018

    Product Code L300; L301; L321; L310; L311; L331; L200; L201; L209; L221; L210; L211; L231; L100; L101; L121; L110; L111; L131; S701; S702; S722; J278; J279; J272; J273; J274; J275; J276; J277; J172; J173; J174; J175; J176; J177; J062; J063; J064; J065; J067

    Part Number 359250-019

    Safety Related Revision Yes

  • RELIANCE™ 4-FRONT

    Instructions for Use

    Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors Extendable/Retractable Fixation

    Mar 01, 2015

    Product Code 0657; 0692; 0693; 0658; 0695; 0696; 0652; 0672; 0673; 0653; 0675; 0676

    Part Number 350065-057

  • RESONATE™ HF CRT-D;RESONATE™ CRT-D;RESONATE™ X4 CRT-D;CHARISMA™ CRT-D;CHARISMA™ X4 CRT-D;VIGILANT™ CRT-D;VIGILANT™ X4 CRT-D;MOMENTUM™ CRT-D;MOMENTUM™ X4 CRT-D

    Reference Guides

    Sep 01, 2016

    Product Code G524, G525, G526, G528, G537, G547, G548, G424, G425, G426, G428, G437, G447, G448, G324, G325, G328, G337, G347, G348, G224, G225, G228, G237, G247, G248, G124, G125, G126, G128, G138

    Part Number 360201-001

  • EMBLEM™ S-ICD

    Instructions for Use

    Subcutaneous Electrode

    Sep 14, 2022

    Product Code 3501

    Part Number 92346953-001

    Applicable To N/A

    Applicable To N/A

    Safety Related Revision No

  • LATITUDE™ HEART CONNECT™

    Operator's Manual;Programming Manuals;Instructions for Use

    Heart Connect™ System

    Aug 14, 2023

    Product Code 3932; 3935; 3936; 3937; 3300; 00802526618505; 3300; 00802526620003; 3300; 00802526618512; 3300; 00802526620331

    Part Number 92302087-001

  • VISIONIST™;VISIONIST™ X4;VALITUDE™;VALITUDE™ X4;INLIVEN™;INTUA™;INVIVE™

    Reference Guides

    CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

    Apr 01, 2018

    Product Code U225; U226; U228; U125; U128; W272; W273; W172; W173; W274; W275

    Part Number 359244-033

    Safety Related Revision Yes

  • LATITUDE™ Communicator

    Patient Information

    LATITUDE™ Communicator

    Apr 01, 2014

    Product Code 6288; 6290

    Part Number 359305-001

  • COGNIS™ 100-D CRT-D;TELIGEN™ 100

    Instructions for Use;Supplemental Updates

    Defibrillator

    Oct 24, 2008

    Product Code F102; F103; F110; F111; P106; P107; P108

    Part Number 358009-001

    Applicable To Important Software Update Information (v1.03)

  • EMBLEM™ S-ICD

    Patient Information

    EMBLEM™ S-ICD System

    Jul 07, 2021

    Product Code

    Part Number 359285-037

    Safety Related Revision No

  • RESONATE™ HF ICD;RESONATE™ EL ICD;PERCIVA™ HF ICD;PERCIVA™ ICD;CHARISMA™ EL ICD;VIGILANT™ EL ICD;MOMENTUM™ EL ICD

    Instructions for Use

    Sep 01, 2016

    Product Code D520, D521, D532, D533, D420, D421, D432, D433, D500, D501, D512, D513 , D400, D401, D412, D413, D320, D321, D332, D333, D220, D221, D232, D233, D120, D121

    Part Number 360204-001

  • LATITUDE Link™

    Integration Guides

    LATITUDE Link™ System

    Aug 01, 2014

    Product Code 6215; 6216

    Part Number 359382-001

    Applicable To HL7 SPECIFICATION

  • VISIONIST™;VISIONIST™ X4;VALITUDE™;VALITUDE™ X4;INLIVEN™;INTUA™;INVIVE™

    Instructions for Use

    CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

    Mar 01, 2018

    Product Code U225; U226; U228; U125; U128; W272; W273; W172; W173; W274; W275

    Part Number 359254-018

    Safety Related Revision Yes

  • ENDOTAK RELIANCE™

    Instructions for Use

    Cardiac Lead

    Feb 01, 2016

    Product Code 0285; 0286; 0282; 0283; 0265; 0266; 0262; 0263

    Part Number 358079-096

    Applicable To Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors Tined Fixation; Pace/Sense and Defibrillation Lead; Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors; Tined Fixation; Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors Tined Fixation; Pace/Sense and Defibrillation Lead; Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors; Tined Fixation; Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors Tined Fixation; Pace/Sense and Defibrillation Lead; Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors; Tined Fixation; Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors Tined Fixation

    Safety Related Revision No

  • LATITUDE Link™

    Instructions for Use;Programming Manuals

    LATITUDE Link™ Data Management System

    Sep 01, 2014

    Product Code 6215; 6216

    Part Number 359387-001

  • EMBLEM™ S-ICD

    Patient Information

    EMBLEM™ S-ICD System

    Oct 01, 2014

    Product Code N/A

    Part Number 359285-001

  • EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

    Instructions for Use

    SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    Nov 01, 2015

    Product Code A209; A219

    Part Number 359481-001

    Safety Related Revision No

  • EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD;EMBLEM™ S-ICD Electrode;Q-TRAK™ S-ICD Electrode;EMBLEM™ S-ICD Programmer

    MRI Information

    Subcutaneous Implantable Cardioverter Defibrillator; Subcutaneous Electrode

    Jan 01, 2019

    Product Code A209; A219; 3400; 3401; 3501

    Part Number 359475-001

    Applicable To IMAGEREADY™

    Safety Related Revision No

  • AUTOGEN™ CRT-D;AUTOGEN™ X4 CRT-D;DYNAGEN™ CRT-D;DYNAGEN™ X4 CRT-D;INOGEN™ CRT-D;INOGEN™ X4 CRT-D;ORIGEN™ CRT-D;ORIGEN™ X4 CRT-D;INCEPTA™ CRT-D;ENERGEN™ CRT-D;PUNCTUA™ CRT-D;COGNIS™ 100-D CRT-D

    Instructions for Use

    CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

    Nov 01, 2017

    Product Code G172; G173;G175; G177; G179; G150; G151; G156; G158; G140; G141; G146; G148; G050; G051; G056; G58; P162; P163; P165; P142; P143; P052; P053; P106; P107; P108

    Part Number 359402-039

    Safety Related Revision No

  • INVIVE™;VALITUDE™;VALITUDE™ X4;INTUA™;VISIONIST™ X4;VISIONIST™

    Patient Information

    Cardiac Resynchronization Therapy

    Jan 01, 2018

    Product Code U225; U226; U228; U125; W272; W273; W172; W173; W274; W292

    Part Number 356396-035

    Safety Related Revision No

  • LATITUDE™ Programming System

    Programming Manuals

    Pacing System Analyzer (PSA)

    Jan 01, 2019

    Product Code 3300; 3922

    Part Number 360164-020

    Applicable To Application for use with the LATITUDE™ Programming System

    Safety Related Revision No

  • VISIONIST™;VISIONIST™ X4;VALITUDE™;VALITUDE™ X4;INLIVEN™;INTUA™;INVIVE™

    Reference Guides

    CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

    Apr 02, 2018

    Product Code U225; U226; U228; U125; U128; W272; W273; W172; W173; W274; W275

    Part Number 359244-017

    Safety Related Revision Yes

  • Q-TECH™ PROGRAMMER;EMBLEM™ S-ICD

    Programming Manuals

    PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHED; Q-TECH™ PROGRAMMIERGERÄT; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMMATEUR Q-TECH™; PROGRAMMATORE Q-TECH™; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHET

    Oct 01, 2013

    Product Code 3200

    Part Number 104749-003

    Applicable To SOUČÁST SYSTÉMU S-ICD®; EN DEL AF S-ICD®-SYSTEMET; EIN BESTANDTEIL DES S-ICD® SYSTEMS; A Component of the S-ICD® System; UN COMPONENTE DEL SISTEMA S-ICD®; COMPOSANT DU SYSTÈME S-ICD®; COMPONENTE DEL SISTEMA S-ICD®; EEN COMPONENT VAN HET S-ICD®-SYSTEEM; UM COMPONENTE DO SISTEMA S-ICD®; SÚČASŤ SYSTÉMU S-ICD®; EN KOMPONENT I S-ICD®-SYSTEMET

  • INGEVITY™+

    Instructions for Use

    Pace/Sense Lead IS-1 Bipolar Connector Extendable/Retractable Fixation

    Oct 27, 2023

    Product Code 7840; 7841; 7842

    Part Number 92383240-001

    Applicable To N/A

    Applicable To N/A

  • FINELINE™ II Sterox;VISIONIST™ X4;INGEVITY™+;FORMIO™ MRI;FINELINE™ II Sterox EZ;ADVANTIO™ MRI;ACCOLADE™ MRI;INGENIO™ MRI;INGEVITY™ MRI;PROPONENT™ MRI;ACUITY™ X4 Spiral L;VITALIO™ MRI;FINELINE™ II;ACUITY™ X4 Straight;ACUITY™ X4 Spiral S;VALITUDE™ X4;ESSENTIO™ MRI

    MRI Information

    IMAGEREADY™ MR Conditional Pacing System

    Mar 23, 2023

    Product Code J065; J066; J067; J175; J176; J177; J275; J276; J277; J279; L110; L111; L131; L210; L211; L231; L310; L311; L331; U128; U228; 4456; 4457; 4458; 4459; 4469; 4470; 4471; 4472; 4473; 4474; 4479; 4480; 4603; 4671; 4672; 4674; 4675; 4677; 4678; 6220; 6221; 6402; 7145; 7148; 7731; 7732; 7735; 7736; 7740; 7741; 7742; 7840; 7841; 7842

    Part Number 359259-054

    Applicable To IMAGEREADY™

    Applicable To N/A

    Safety Related Revision No

  • RELIANCE™ 4-FRONT

    Instructions for Use

    Cardiac Lead

    Jun 11, 2012

    Product Code 0657; 0658; 0675; 0676; 0692; 0693; 0695; 0696

    Part Number 350065-019

    Applicable To Pace/Sense and Defibrillation Lead; Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors; Extendable/Retractable Fixation

  • ENDOTAK RELIANCE™

    Instructions for Use

    Cardiac Lead

    Feb 01, 2016

    Product Code 0262; 0263; 0265; 0266; 0282; 0283; 0285; 0286

    Part Number 358079-079

    Applicable To Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors Tined Fixation; Pace/Sense and Defibrillation Lead; Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors; Tined Fixation

    Safety Related Revision No

  • INGEVITY™ MRI

    Instructions for Use

    Cardiac Lead

    Mar 02, 2015

    Product Code 7740; 7741; 7742

    Part Number 358659-041

    Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Extendable/Retractable Fixation; Pace/Sense Lead IS-1 Bipolar Connector Extendable/Retractable Fixation

    Safety Related Revision No

  • EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

    Instructions for Use

    SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    Oct 01, 2018

    Product Code A209; A219

    Part Number 359481-037

    Safety Related Revision No

  • LATITUDE™ Programming System

    Programming Manuals

    Patient Data Management

    Mar 01, 2017

    Product Code 3300

    Part Number 92059496-001

  • EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

    Programming Manuals

    S-ICD Programmer

    Oct 01, 2015

    Product Code 3200

    Part Number 359465-001

    Safety Related Revision No

  • LATITUDE™ Communicator

    Supplemental Updates;Patient Information

    Komunikátor LATITUDE™ ; LATITUDE™ Kommunikator ; LATITUDE™ Communicator ; Συσκευή επικοινωνίας LATITUDE™; LATITUDE™ Communicator; Comunicador LATITUDE™ ; Communicateur LATITUDE™ ; Comunicatore LATITUDE™ ; LATITUDE™ Communicator ; LATITUDE™ Kommunikator ; Komunikator LATITUDE™ ; Comunicador LATITUDE™; Komunikátor LATITUDE™ ; LATITUDE™ Kommunikator; LATITUDE™ Communicator; Communicateur LATITUDE™

    May 20, 2022

    Product Code 6545; 6288; 6290

    Part Number 359426-001

    Applicable To LATITUDE™ Communicator Patient Manual Supplement Hotspot Feature; Supplément au Manuel patient du Communicateur LATITUDE™ pour la fonction Hotspot; Dodatek k příručce pro pacienty ke komunikátoru LATITUDE™ k funkci Hotspot; Patienthåndbog til LATITUDE™-kommunicatoren – Supplement til Hotspot-funktion; LATITUDE™ Ergänzung zum Communicator- Patientenhandbuch für die Hotspot-Funktion; Συμπληρωματικό εγχειρίδιο Συσκευής επικοινωνίας LATITUDE™ για τον ασθενή - Λειτουργία Hotspot; LATITUDE™ Communicator Patient Manual Supplement Hotspot Feature; Apéndice del Manual del comunicador del paciente LATITUDE™: función de punto de acceso; Supplément au Manuel patient du Communicateur LATITUDE™ pour la fonction Hotspot; Supplemento al manuale per il paziente del Comunicatore LATITUDE™ relativo alla funzione hotspot; Aanvulling op de LATITUDE™ Communicator Patiëntenhandleiding voor de hotspotfunctie; Tillegg til pasienthåndbok for LATITUDE™-kommunikator – Hotspot-funksjonen; Suplement do Instrukcji obsługi komunikatora LATITUDE™ dla pacjenta dotyczący funkcji hotspot; Suplemento do Manual do Comunicador do Paciente LATITUDE™ para Funcionalidade Hotspot; Doplnok k manuálu komunikátora LATITUDE™ pre pacienta – funkcia Hotspot; Bilaga om hotspot-funktion till patienthandbok till LATITUDE™-kommunikator; LATITUDE™ Communicator Patient Manual Supplement Hotspot Feature

    Safety Related Revision No

  • INGEVITY™ MRI

    Instructions for Use

    Cardiac Lead

    May 01, 2018

    Product Code 7740; 7741; 7742

    Part Number 358659-041

    Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Extendable/Retractable Fixation; Pace/Sense Lead IS-1 Bipolar Connector Extendable/Retractable Fixation

    Safety Related Revision No

  • myLUX™;LUX-Dx™

    Patient Information

    myLUX™ Patient App for Insertable Cardiac Monitor

    May 29, 2024

    Product Code M301; 2925; 6259

    Part Number 92216680-001

    Safety Related Revision Blank

  • INGEVITY™ MRI

    Instructions for Use

    Cardiac Lead

    Dec 01, 2014

    Product Code 7740; 7741; 7742

    Part Number 358659-023

    Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Extendable/Retractable Fixation

    Safety Related Revision No

  • LATITUDE™ Programming System

    Programming Manuals

    Programmer

    Jun 01, 2019

    Product Code 3300

    Part Number 359488-020

    Safety Related Revision No

  • ENERGEN™ ICD

    Reference Guides

    IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATOR

    Nov 13, 2012

    Product Code F140; F141; F142; F143

    Part Number 358427-018

    Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

  • ACCOLADE™;ACCOLADE™ MRI;PROPONENT™;PROPONENT™ MRI;ESSENTIO™;ESSENTIO™ MRI;ALTRUA™ 2;FORMIO™;FORMIO™ MRI;VITALIO™;VITALIO™ MRI;INGENIO™;INGENIO™ MRI;ADVANTIO™;ADVANTIO™ MRI

    Reference Guides

    PACEMAKER

    Apr 01, 2018

    Product Code L300; L301; L321; L310; L311; L331; L200; L201; L209; L221; L210; L211; L231; L100; L101; L121; L110; L111; L131; S701; S702; S722; J278; J279; J272; J273; J274; J275; J276; J277; J172; J173; J174; J175; J176; J177; J178; J062; J063; J064; J065; J066; J067

    Part Number 359241-017

    Safety Related Revision Yes

  • PUNCTUA™ ICD;PUNCTUA™ NE ICD

    Reference Guides

    IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATOR

    Nov 13, 2012

    Product Code F050; F051; F052; F053

    Part Number 358359-018

    Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

  • LATITUDE™

    Clinician Manuals;Integration Guides

    LATITUDE NXT Patient Management System

    Jul 01, 2022

    Product Code 6624; 6455

    Part Number 359483-012

    Applicable To LATITUDE™ NXT - LATITUDE INTEGRATION IDCO AND HL7 SPECIFICATIONS

    Safety Related Revision No

  • INCEPTA™ ICD

    Reference Guides

    IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATOR

    Nov 13, 2012

    Product Code F160; F161; F162; F163

    Part Number 358431-022

    Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

  • AUTOGEN™ CRT-D;AUTOGEN™ X4 CRT-D;DYNAGEN™ CRT-D;DYNAGEN™ X4 CRT-D;INOGEN™ CRT-D;INOGEN™ X4 CRT-D;ORIGEN™ CRT-D;ORIGEN™ X4 CRT-D

    Instructions for Use

    CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

    Nov 17, 2013

    Product Code G172; G173; G175; G177; G179; G150; G151; G156; G158; G140; G141; G146; G148; G050; G051; G056; G058

    Part Number 359059-019

  • LATITUDE™ Programming System

    Programming Manuals

    Patient Data Management

    Apr 22, 2022

    Product Code 3300; 3931

    Part Number 360194-039

    Applicable To Application for use with the LATITUDE™ Programming System

    Safety Related Revision No

  • EMBLEM™ S-ICD

    Instructions for Use

    Electrode Delivery System

    Sep 14, 2022

    Product Code 4712

    Part Number 92363957-001

    Applicable To N/A

    Applicable To N/A

    Safety Related Revision No

  • LATITUDE™ Programming System

    Programming Manuals

    Pacing System Analyzer (PSA)

    Mar 01, 2017

    Product Code 3300; 3922

    Part Number 360164-001

    Applicable To Application for use with the LATITUDE™ Programming System

  • EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

    Instructions for Use

    Subcutaneous Electrode Insertion Tool

    Nov 01, 2016

    Product Code 4711

    Part Number 359472-019

    Safety Related Revision No

  • LATITUDE™ Programming System

    Programming Manuals

    Patient Data Management

    Feb 01, 2018

    Product Code 3300; 3931

    Part Number 360194-020

    Applicable To Application for use with the LATITUDE™ Programming System

    Safety Related Revision No

  • AUTOGEN™ EL ICD;AUTOGEN™ MINI ICD;DYNAGEN™ EL ICD;DYNAGEN™ MINI ICD;INOGEN™ EL ICD;INOGEN™ MINI ICD;ORIGEN™ EL ICD;ORIGEN™ MINI ICD

    Instructions for Use

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    Nov 17, 2013

    Product Code D174; D175; D176; D177; D044; D045; D046; D047; D150; D151; D152; D153; D020; D021; D022; D023; D140; D141; D142; D143; D010; D011; D012; D013; D050; D051; D052; D053; D000; D001; D002; D003

    Part Number 359060-001

  • LATITUDE™

    Clinician Manuals

    LATITUDE NXT Patient Management System

    Sep 01, 2016

    Product Code 6446; 6448

    Part Number 358827-052

    Safety Related Revision No

  • AUTOGEN™ EL ICD;AUTOGEN™ MINI ICD;DYNAGEN™ EL ICD;DYNAGEN™ MINI ICD;INOGEN™ EL ICD;INOGEN™ MINI ICD;ORIGEN™ EL ICD;ORIGEN™ MINI ICD

    Reference Guides

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    Nov 17, 2013

    Product Code D174; D175; D176; D177; D044; D045; D046; D047; D150; D151; D152; D153; D020; D021; D022; D023; D140; D141; D142; D143; D010; D011; D012; D013; D050; D051; D052; D053; D000; D001; D002; D003

    Part Number 359211-001

  • EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

    Instructions for Use

    Subcutaneous Electrode

    Sep 01, 2016

    Product Code 3401

    Part Number 359469-019

    Safety Related Revision No

  • LATITUDE™ NXT

    Clinician Manuals

    LATITUDE NXT Patient Management System

    Oct 27, 2023

    Product Code 6468; 6496; 6446; 00802526613821; 6448; 00802526613814; 6288; 00802526617508; 6288; 00802526617423; 6288; 00802526577376; 6288; 00802526577383; 6288; 00802526616518; 6288; 00802526577413; 6288; 00802526617409; 6290; 00802526617805; 6290; 00802526617843; 6290; 00802526585678; 6290; 00802526585685; 6290; 00802526617812; 6290; 00802526585715; 6290; 00802526617829; 6290; 00802526617836; 6290; 00802526585739; 6290; 00802526606236; 6290; 00802526618918; 6290; 00802526606212

    Part Number 92436023-001

    Safety Related Revision No

  • TELIGEN™ 100

    Instructions for Use

    IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATOR

    Nov 09, 2012

    Product Code F102; F103; F110; F111

    Part Number 357481-067

    Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

  • Q-TECH™ PROGRAMMER;EMBLEM™ S-ICD

    Programming Manuals

    PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHED; Q-TECH™ PROGRAMMIERGERÄT; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMMATEUR Q-TECH™; PROGRAMMATORE Q-TECH™; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHET

    Jun 01, 2010

    Product Code 2020

    Part Number 102099-109

    Applicable To SOUČÁST SYSTÉMU S-ICD®; EN DEL AF S-ICD®-SYSTEMET; EIN BESTANDTEIL DES S-ICD® SYSTEMS; A Component of the S-ICD® System; UN COMPONENTE DEL SISTEMA S-ICD®; COMPOSANT DU SYSTÈME S-ICD®; COMPONENTE DEL SISTEMA S-ICD®; EEN COMPONENT VAN HET S-ICD®-SYSTEEM; UM COMPONENTE DO SISTEMA S-ICD®; SÚČASŤ SYSTÉMU S-ICD®; EN KOMPONENT I S-ICD®-SYSTEMET

  • ACUITY™ X4 Spiral S;ACUITY™ X4 Spiral L;ACUITY™ X4 Straight

    Instructions for Use

    Cardiac Lead

    Mar 01, 2015

    Product Code 4671; 4672; 4674; 4675; 4677; 4678

    Part Number 359161-020

    Applicable To Coronary Venous; Pace/Sense Lead; IS4 Four-Pole Connector

    Safety Related Revision No

  • LATITUDE™

    Clinician Manuals

    LATITUDE NXT Patient Management System

    Oct 01, 2018

    Product Code 6446; 6448

    Part Number 358827-075

    Safety Related Revision No

  • AUTOGEN™ CRT-D;AUTOGEN™ X4 CRT-D;DYNAGEN™ CRT-D;DYNAGEN™ X4 CRT-D;INOGEN™ CRT-D;INOGEN™ X4 CRT-D;ORIGEN™ CRT-D;ORIGEN™ X4 CRT-D;INCEPTA™ CRT-D;ENERGEN™ CRT-D;PUNCTUA™ CRT-D;COGNIS™ 100-D CRT-D

    Reference Guides

    CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

    Nov 01, 2017

    Product Code G172; G173; G175; G177; G179; G150; G151; G156; G158; G140; G141; G146; G148; G050; G051; G056; G58; P162; P163; P165; P142; P143; P052; P053; P106; P107; P108

    Part Number 359406-033

    Safety Related Revision No

  • 3300 LATITUDE™ Programming System

    Programming Manuals

    Network and Connectivity

    Jul 31, 2023

    Product Code 3924; 3300; 00802526618505; 3300; 00802526620003; 3300; 00802526618512; 3300; 00802526620331

    Part Number 92362143-001

    Applicable To Application for use with the LATITUDE™ Programming System

    Safety Related Revision No

  • Q-TECH™ PROGRAMMER;EMBLEM™ S-ICD

    Programming Manuals

    PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHED; Q-TECH™ PROGRAMMIERGERÄT; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMMATEUR Q-TECH™; PROGRAMMATORE Q-TECH™; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHET

    Jul 01, 2014

    Product Code 3200

    Part Number 104749-004

    Applicable To SOUČÁST SYSTÉMU S-ICD®; EN DEL AF S-ICD®-SYSTEMET; EIN BESTANDTEIL DES S-ICD® SYSTEMS; A Component of the S-ICD® System; UN COMPONENTE DEL SISTEMA S-ICD®; COMPOSANT DU SYSTÈME S-ICD®; COMPONENTE DEL SISTEMA S-ICD®; EEN COMPONENT VAN HET S-ICD®-SYSTEEM; UM COMPONENTE DO SISTEMA S-ICD®; SÚČASŤ SYSTÉMU S-ICD®; EN KOMPONENT I S-ICD®-SYSTEMET

  • ACCOLADE™;ACCOLADE™ MRI;PROPONENT™;PROPONENT™ MRI;ESSENTIO™;ESSENTIO™ MRI;ALTRUA™ 2;FORMIO™;FORMIO™ MRI;VITALIO™;VITALIO™ MRI;INGENIO™;INGENIO™ MRI;ADVANTIO™;ADVANTIO™ MRI

    Instructions for Use

    PACEMAKER

    Oct 06, 2014

    Product Code L300; L301; L321; L310; L311; L331; L200; L201; L209; L221; L210; L211; L231; L100; L101; L121; L110; L111; L131; S701; S702; S722; J278; J279; J272; J273; J274; J275; J276; J277; J172; J173; J174; J175; J176; J177; J178; J062; J063; J064; J065; J066; J067

    Part Number 359250-001

  • INCEPTA™ CRT-D

    Reference Guides

    CARDIAC RESYNCHRONIZATION THERAPY HIGH ENERGY DEFIBRILLATOR

    Nov 13, 2012

    Product Code P162; P163; P165

    Part Number 358440-023

    Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

  • Q-TECH™ PROGRAMMER;EMBLEM™ S-ICD

    Programming Manuals

    PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHED; Q-TECH™ PROGRAMMIERGERÄT; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMMATEUR Q-TECH™; PROGRAMMATORE Q-TECH™; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHET

    Feb 01, 2013

    Product Code 2020

    Part Number 102099-010

    Applicable To SOUČÁST SYSTÉMU S-ICD®; EN DEL AF S-ICD®-SYSTEMET; EIN BESTANDTEIL DES S-ICD® SYSTEMS; A Component of the S-ICD® System; UN COMPONENTE DEL SISTEMA S-ICD®; COMPOSANT DU SYSTÈME S-ICD®; COMPONENTE DEL SISTEMA S-ICD®; EEN COMPONENT VAN HET S-ICD®-SYSTEEM; UM COMPONENTE DO SISTEMA S-ICD®; SÚČASŤ SYSTÉMU S-ICD®; EN KOMPONENT I S-ICD®-SYSTEMET

  • VIGILANT™ CRT-D;MOMENTUM™ EL ICD VR;CHARISMA™ CRT-D;RESONATE™ HF ICD;RESONATE™ CRT-D;PERCIVA™ HF ICD;LATITUDE™ Communicator;MOMENTUM™ CRT-D;RESONATE™ EL ICD DR;PERCIVA™ ICD VR;VIGILANT™ X4 CRT-D;RESONATE™ HF CRT-D;RESONATE™ X4 CRT-D;CHARISMA™ EL ICD VR;CHARISMA™ X4 CRT-D;MOMENTUM™ X4 CRT-D;MOMENTUM™ EL ICD DR;RESONATE™ EL ICD VR;LATITUDE™ Programming System;VIGILANT™ EL ICD;CHARISMA™ EL ICD DR;PERCIVA™ ICD DR

    Instructions for Use

    Oct 12, 2021

    Product Code 3300, 6290, D500, D501, D512, D513, D520, D521, D532, D533, G524, G525, G526, G528, G537, G547, G548, D120, D121, D220, D221, D232, D233, D320, D321, D332, D333, D400, D401, D412, D413, D420, D421, D432, D433, G124, G125, G126, G128, G138, G224, G225, G228,G237 G247, G248, G324, G325, G328, G337, G347, G348, G424, G425, G426, G428, G437, G447, G448

    Part Number 360206-019

    Safety Related Revision No

  • ACUITY™ Spiral

    Instructions for Use

    Implantable Lead

    Oct 26, 2023

    Product Code 4591; 4592; 4593

    Part Number 357272-032

  • RELIANCE™ 4-FRONT

    Patient Information

    Cardiac Lead

    Jul 25, 2023

    Product Code 0672; 0673; 0675; 0676; 0652; 0653; 0657; 0658; 0692; 0693; 0695; 0696; 0636; 0662; 0663; 0665; 0650; 0651; 0654; 0655; 0682; 0683; 0685; 0686

    Part Number 51070663-001

  • COGNIS™ CRT-D;TELIGEN™ ICD;PUNCTUA™;ENERGEN™ CRT-D;INCEPTA™;AUTOGEN™ CRT-D;DYNAGEN™;INOGEN™ CRT-D;ORIGEN™ ICD;ORIGEN™ CRT-D

    Reference Guides;Supplemental Updates

    Defibrillator

    May 28, 2014

    Product Code D050; D051; D052; D053; D000; D001; D002; D003; D140; D141; D142; D143; D010; D011; D012; D013; D150; D151; D152; D153; D020; D021; D022; D023; D174; D175; D176; D177; D044; D045; D046; D047; G050; G051; G056; G058; G140; G141; G146; G148; G150; G151; G156; G158; G172; G173; G175; G177; G179; F050; F051; F052; F053; F140; F141; F142; F143; F160; F161; F162; F163; P052; P053; P142; P143; P162; P163; P165; P106; P107; P108; F102; F103; F110; F111

    Part Number 359319-001

    Applicable To Reference Guide Update

  • ACUITY™ X4 Spiral L;ACUITY™ X4 Spiral S;ACUITY™ X4 Straight;AUTOGEN™ X4 CRT-D;AUTOGEN™ EL ICD;DYNAGEN™ X4 CRT-D;DYNAGEN™ EL ICD;ENDOTAK RELIANCE™;FINELINE™ II;INGEVITY™ MRI;INOGEN™ EL ICD;INOGEN™ MINI ICD;INOGEN™ X4 CRT-D;ORIGEN™ EL ICD;ORIGEN™ MINI ICD;ORIGEN™ X4 CRT-D;RELIANCE™ 4-FRONT;RESONATE™ CRT-D

    MRI Information

    Defibrillator

    Apr 01, 2015

    Product Code D000; D002; D010; D012; D020; D022; D044; D046; D050; D052; D140; D142; D150; D152; D174; D176; G058; G148; G158; G179; 0265; 0266; 0275; 0276; 0282; 0283; 0285; 0286; 0292; 0293; 0295; 0296; 0636; 0654; 0655; 0657; 0658; 0665; 0675; 0676; 0682; 0683; 0685; 0686; 0692; 0693; 0695; 0696; 4469; 4470; 4471; 4472; 4473; 4474; 4479; 4480; 4603; 4671; 4672; 4674; 4675; 4677; 4678; 6220; 6221; 6402; 6403; 7145; 7735; 7736; 7740; 7741; 7742

    Part Number 359447-001

    Applicable To IMAGEREADY™

    Safety Related Revision No

  • EMBLEM™ S-ICD

    Patient Information

    EMBLEM™ S-ICD System

    Oct 01, 2015

    Product Code N/A

    Part Number 359285-019

    Safety Related Revision No

  • ENERGEN™ CRT-D

    Reference Guides

    CARDIAC RESYNCHRONIZATION THERAPY HIGH ENERGY DEFIBRILLATOR

    Nov 13, 2012

    Product Code P142; P143

    Part Number 358435-018

    Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

  • LATITUDE™ Programming System

    Programming Manuals

    Pacing System Analyzer (PSA)

    Jul 07, 2022

    Product Code 3300; 3922

    Part Number 360164-077

    Applicable To Application for use with the LATITUDE™ Programming System

    Safety Related Revision No

  • DYNAGEN™ X4 CRT-D;AUTOGEN™ X4 CRT-D;ORIGEN™ X4 CRT-D;INOGEN™ X4 CRT-D

    Reference Guides;Supplemental Updates;Instructions for Use

    Defibrillator

    Oct 01, 2014

    Product Code N/A

    Part Number 359386-001

    Applicable To This update provides information about the PaceSafeTM LVAT feature and LV VectorGuideTM for AUTOGENTM X4, DYNAGENTM X4, INOGENTM X4, and ORIGENTM X4 devices.; This update provides information about the PaceSafe™ LVAT feature and LV VectorGuide™ for AUTOGEN™ X4, DYNAGEN™ X4, INOGEN™ X4, and ORIGEN™ X4 devices.

  • LATITUDE™

    Integration Guides

    LATITUDE NXT Patient Management System

    Oct 01, 2015

    Product Code 6624

    Part Number 359483-001

    Applicable To LATITUDE™ NXT - LATITUDE INTEGRATION IDCO AND HL7 SPECIFICATIONS

    Safety Related Revision No

  • ENDOTAK RELIANCE™

    Instructions for Use

    Cardiac Lead

    Feb 01, 2017

    Product Code 0295; 0296; 0292; 0293; 0275; 0276; 0272; 0273

    Part Number 358074-119

    Applicable To Pace/Sense and Defibrillation Lead, Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors, Extendable/Retractable Fixation; Pace/Sense and Defibrillation Lead; Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors; Extendable/Retractable Fixation; Pace/Sense and Defibrillation Lead, Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors, Extendable/Retractable Fixation; Pace/Sense and Defibrillation Lead; Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors; Extendable/Retractable Fixation; Pace/Sense and Defibrillation Lead, Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors, Extendable/Retractable Fixation

    Safety Related Revision No

  • EMBLEM™ S-ICD;3300 LATITUDE™ Programming System

    Operator's Manual;Programming Manuals;Instructions for Use

    Jul 07, 2022

    Product Code 3877; 3300

    Part Number 92123952-001

  • RELIANCE™ 4-FRONT

    Instructions for Use

    Cardiac Lead

    Feb 07, 2013

    Product Code 0636; 0654; 0655; 0665; 0682; 0683; 0685; 0686

    Part Number 350063-045

    Applicable To Pace/Sense and Defibrillation Lead, Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors, Tined Fixation

  • DYNAGEN™ X4 CRT-D;VIGILANT™ EL ICD;INOGEN™ CRT-D;INGEVITY™ MRI;AUTOGEN™ MINI ICD;VIGILANT™ X4 CRT-D;CHARISMA™ EL ICD;ORIGEN™ CRT-D;INOGEN™ MINI ICD;AUTOGEN™ X4 CRT-D;RESONATE™ HF ICD;ACUITY™ Spiral;ENDOTAK RELIANCE™;AUTOGEN™ CRT-D;MOMENTUM™ EL ICD;DYNAGEN™ CRT-D;RESONATE™ EL ICD;ORIGEN™ MINI ICD;VIGILANT™ CRT-D;EASYTRAK™ 2;INOGEN™ EL ICD;ORIGEN™ EL ICD;RELIANCE™ 4-FRONT;ACUITY™ X4 Spiral L;PERCIVA™ HF ICD;RESONATE™ HF CRT-D;DYNAGEN™ EL ICD;DYNAGEN™ MINI ICD;RESONATE™ X4 CRT-D;ACUITY™ X4 Straight;FINELINE™ II;ACUITY™ X4 Spiral S;MOMENTUM™ X4 CRT-D;INOGEN™ X4 CRT-D;PERCIVA™ ICD;ORIGEN™ X4 CRT-D;RESONATE™ CRT-D;CHARISMA™ CRT-D;AUTOGEN™ EL ICD;MOMENTUM™ CRT-D;CHARISMA™ X4 CRT-D

    MRI Patient Guides;MRI Information

    Defibrillator

    Feb 01, 2015

    Product Code D000; D002; D010; D012; D020; D022; D044; D046; D050; D052; D140; D142; D150; D152; D174; D176; D232; D233; D332; D333; D412; D413; D432; D433; D512; D513; D532; D533; G058; G148; G158; G179; G237; G247; G337;G347; G437; G447; G537; G547; 0262; 0263; 0265; 0266; 0272; 0273; 0275; 0276; 0282; 0283; 0285; 0286; 0292; 0293; 0295; 0296; 0636; 0650; 0651; 0652; 0653; 0654; 0655; 0657; 0658; 0662; 0663; 0665; 0672; 0673; 0675; 0676; 0682; 0683; 0685; 0686; 0692; 0693; 0695; 0696; 4469; 4470; 4471; 4472; 4473; 4474; 4479; 4480; 4603; 4671; 4672; 4674; 4675; 4677; 4678; 6220; 6221; 6402; 6403; 7145; 7148; 7735; 7736; 7740; 7741; 7742

    Part Number 359446-001

    Applicable To ImageReady™ MR Conditional Defibrillation System - Patient Guide for MRI Scans

  • ACCOLADE™ MRI;ACUITY™ X4 Spiral L;ACUITY™ X4 Spiral S;ACUITY™ X4 Straight;ADVANTIO™ MRI;ESSENTIO™ MRI;FINELINE™ II;FORMIO™ MRI;INGENIO™ MRI;INGEVITY™ MRI;PROPONENT™ MRI;VALITUDE™ X4;VISIONIST™ X4;VITALIO™ MRI

    MRI Information

    Pacemaker

    Oct 06, 2014

    Product Code J065; J066; J067; J175; J176; J177; J275; J276; J277; J279; L110; L111; L131; L210; L211; L231; L310; L311; L331; 4456; 4457; 4458; 4459; 4469; 4470; 4471; 4472; 4473; 4474; 4479; 4480; 6220; 6221; 6402; 7145; 7731; 7732; 7735; 7736; 7740; 7741; 7742

    Part Number 359259-018

    Applicable To IMAGEREADY™

  • Q-TECH™ PROGRAMMER;EMBLEM™ S-ICD

    Programming Manuals

    Q-TECH™ PROGRAMMERINGSENHED; Q-TECH™ PROGRAMMIERGERÄT; Q-TECH™ PROGRAMMER; PROGRAMMATORE Q-TECH™; Q-TECH™ PROGRAMMER

    May 01, 2013

    Product Code 3200

    Part Number 104749-001

    Applicable To EN DEL AF S-ICD®-SYSTEMET; EIN BESTANDTEIL DES S-ICD® SYSTEMS; A Component of the S-ICD® System; COMPONENTE DEL SISTEMA S-ICD®; EEN COMPONENT VAN HET S-ICD®-SYSTEEM

  • LATITUDE™ Communicator

    Supplemental Updates;Patient Information

    Change to your LATITUDE™ Communicator Connection Method; Změňte metodu připojení svého komunikátoru LATITUDE™; Ændring til forbindelsesmåde for din LATITUDE™-kommunikator; Änderungen an Ihrer LATITUDE™ Communicator-Verbindungsmethode; Αλλαγή στη μέθοδο σύνδεσης της Συσκευής επικοινωνίας LATITUDE™; Cambio en el método de conexión del comunicador LATITUDE™; muutos LATITUDE™ yhteydenpitolaitteen yhteysmenetelmään; Modification de la méthode de connexion de votre CommunicatEU; FIr LATITUDE™; A LATITUDE™ kommunikátor csatlakozási módszerének módosítása; Modifica al metodo di connessione del Comunicatore LATITUDE™; wijziging in de verbindingsmethode voor uw LATITUDE Communicator; endring i tilkoblingsmetoden for LATITUDE™-kommunikator; Zmiana metody połączenia komunikatora LATITUDE™; Alteração do método de ligação do sEU; FI Comunicador LATITUDE™; Zmena metódy pripojenia komunikátora LATITUDE™; Ändra anslutningsmetoden i din LATITUDE™ kommunikator

    Jul 01, 2022

    Product Code 6280, 6288, 6290, 6420, 6443, 6468, 6476, 6481, 6482, 6496, 6498

    Part Number 360235-001

    Safety Related Revision No

  • LATITUDE Link™

    Instructions for Use;Programming Manuals

    LATITUDE Link™ DATA MANAGEMENT SYSTEM

    Oct 01, 2015

    Product Code 6215; 6216

    Part Number 359484-001

    Applicable To INSTALLATION AND OPERATION GUIDE

    Safety Related Revision No

  • ACCOLADE™;ACCOLADE™ MRI;PROPONENT™;PROPONENT™ MRI;ESSENTIO™;ESSENTIO™ MRI;ALTRUA™ 2;FORMIO™;FORMIO™ MRI;VITALIO™;VITALIO™ MRI;INGENIO™;INGENIO™ MRI;ADVANTIO™;ADVANTIO™ MRI

    Instructions for Use

    Pacemaker

    Mar 02, 2018

    Product Code L300; L301; L321; L310; L311; L331; L200; L201; L209; L221; L210; L211; L231; L100; L101; L121; L110; L111; L131; S701; S702; S722; J278; J279; J272; J273; J274; J275; J276; J277; J172; J173; J174; J175; J176; J177; J062; J063; J064; J065; J067

    Part Number 359250-037

    Safety Related Revision Yes

  • ACCOLADE™ MRI;ACUITY™ X4 Spiral L;ACUITY™ X4 Spiral S;ACUITY™ X4 Straight;ADVANTIO™ MRI;ESSENTIO™ MRI;FINELINE™ II;FORMIO™ MRI;INGENIO™ MRI;INGEVITY™ MRI;PROPONENT™ MRI;VALITUDE™ X4;VISIONIST™ X4;VITALIO™ MRI

    MRI Information

    Pacemaker

    Nov 01, 2018

    Product Code J065; J066; J067; J175; J176; J177; J275; J276; J277; J279; L110; ;L111; L131; L210; L211; L231; L310; L311; L331; U128; U228; 4456; 4457; 4458; 4459; 4469; 4470; 4471; 4472; 4473;4474; 4479; 4480; 4603; 4671; 4672; 4674; 4675; 4676; 4677; 4678; 6220; 6221; 6402; 7145; 7148; 7731; 7732; 7735; 7736; 7740; 7741; 7742

    Part Number 359259-019

    Applicable To IMAGEREADY™

    Safety Related Revision Yes

  • LATITUDE™ Communicator

    Patient Information

    LATITUDE™ Communicator

    Jun 01, 2018

    Product Code 6288; 6290

    Part Number 359419-020

    Safety Related Revision No

  • VALITUDE™;VISIONIST™ X4;INTUA™;INVIVE™;INLIVEN™;VALITUDE™ X4;VISIONIST™

    Instructions for Use

    CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

    Jun 18, 2024

    Product Code U225; U226; U228; U125; U128; W272; W273; W172; W173; W274; W275

    Part Number 359254-035

    Safety Related Revision Yes

  • ACUITY™ X4 Spiral L;ACUITY™ X4 Straight;ACUITY™ X4 Spiral S

    Instructions for Use

    Cardiac Lead

    Dec 01, 2023

    Product Code 4671; 4672; 4674; 4675; 4677; 4678

    Part Number 92035847-019

    Safety Related Revision No

  • LATITUDE™

    Integration Guides

    LATITUDE Patient Management System

    Feb 01, 2015

    Product Code 6624

    Part Number 350011-018

    Applicable To LATITUDE INTEGRATION HL7 SPECIFICATION

    Safety Related Revision No

  • Q-TECH™ PROGRAMMER;EMBLEM™ S-ICD

    Programming Manuals

    PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHED; Q-TECH™ PROGRAMMIERGERÄT; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMMATEUR Q-TECH™; Q-TECH™ PROGRAMMER; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHET

    Jan 01, 2010

    Product Code 2020

    Part Number 102099-107

    Applicable To SOUČÁST SYSTÉMU S-ICD®; EN DEL AF S-ICD®-SYSTEMET,; EIN BESTANDTEIL DES S-ICD® SYSTEMS; A Component of the S-ICD® System; UN COMPONENTE DEL SISTEMA S-ICD®; COMPOSANT DU SYSTÈME S-ICD®; COMPONENTE DEL SISTEMA S-ICD®; EEN COMPONENT VAN HET S-ICD®-SYSTEEM; UM COMPONENTE DO SISTEMA S-ICD®,; SÚČASŤ SYSTÉMU S-ICD®; EN KOMPONENT I S-ICD®-SYSTEMET

  • INGEVITY™ MRI

    Instructions for Use

    Cardiac Lead

    May 01, 2018

    Product Code 7731; 7732; 7735; 7736

    Part Number 358661-112

    Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Tined Fixation

    Safety Related Revision No

  • LATITUDE™ Communicator

    Patient Information

    QUICK START GUIDE

    Mar 28, 2024

    Product Code 6288; 00802526616518; 6288; 00802526617423; 6288; 00802526617409; 6288; 00802526577383; 6288; 00802526577376; 6288; 00802526617508; 6290; 00802526617805; 6290; 00802526617843; 6290; 00802526585678; 6290; 00802526585685; 6290; 00802526617812; 6290; 00802526617829; 6290; 00802526617836

    Part Number 92436021-001

    Safety Related Revision Blank

  • RELIANCE™ 4-FRONT

    Instructions for Use

    Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and DF4-LLHO Connectors Extendable/Retractable Fixation

    Jul 14, 2022

    Product Code 0657; 0692; 0693; 0658; 0695; 0696; 0652; 0672; 0673; 0653; 0675; 0676

    Part Number 350065-075

    Safety Related Revision No

  • LATITUDE™

    Clinician Manuals

    LATITUDE NXT Patient Management System

    Jul 01, 2022

    Product Code 6280; 6288; 6290; 6446; 6447; 6448; 6468; 6496; 6498

    Part Number 358827-075

    Safety Related Revision No

  • EMBLEM™ S-ICD;EMBLEM™ MRI S-ICD

    Instructions for Use

    SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    Sep 14, 2022

    Product Code A219; A209

    Part Number 92346913-001

    Applicable To N/A

    Applicable To N/A

    Safety Related Revision No

  • RESONATE™ HF CRT-D;RESONATE™ CRT-D;RESONATE™ X4 CRT-D;CHARISMA™ CRT-D;CHARISMA™ X4 CRT-D;VIGILANT™ CRT-D;VIGILANT™ X4 CRT-D;MOMENTUM™ CRT-D;MOMENTUM™ X4 CRT-D

    Instructions for Use

    Sep 01, 2016

    Product Code G524, G525, G526, G528, G537, G547, G548, G424, G425, G426, G428, G437, G447, G448, G324, G325, G328, G337, G347, G348, G224, G225, G228, G237, G247, G248, G124, G125, G126, G128, G138

    Part Number 360203-001

  • LATITUDE™ Communicator

    Supplemental Updates;Patient Information

    komunikátoru LATITUDE™ k ethernetovému adaptéru USB; LATITUDE™ Kommunicatoren – Supplement til USB Ethernet-adapter; LATITUDE™ Communicator-USB-Ethernet-Adapter; Συμπληρωματικό εγχειρίδιο χρήσης Συσκευής επικοινωνίας LATITUDE™ για τον ασθενή Προσαρμογέας Ethernet USB; comunicador del paciente para el adaptador USB de Ethernet LATITUDE™; Communicateur LATITUDE™ pour l´adaptateur Ethernet USB; Comunicatore LATITUDE™ relativo all'adattatore Ethernet USB; LATITUDE™ Communicator USB-ethernetadapter; LATITUDE™-kommunikator – USB-Ethernet-adapter; komunikatora LATITUDE™ dla pacjenta dotyczący adaptera USB do sieci Ethernet; Comunicador LATITUDE™ do Paciente para o Adaptador Ethernet USB; komunikátora LATITUDE™ pre pacienta – adaptér USB Ethernet; USB-Ethernet-adapter till LATITUDE™ kommunikator; LATITUDE™ Communicator - USB Ethernet Adapter; Communicateur LATITUDE™ pour l´adaptateur Ethernet USB

    May 20, 2022

    Product Code 6293

    Part Number 359337-001

    Applicable To LATITUDE™ - Communicator Patient Manual Supplement; LATITUDE™ - Suplemento do Manual do Paciente do Comunicador; Dodatek k příručce pro pacienty ke komunikátoru LATITUDE™ k ethernetovému adaptéru USB; Patienthåndbog til LATITUDE™ Kommunicatoren – Supplement til USB Ethernet-adapter; LATITUDE™ Ergänzung zum Communicator- Patientenhandbuch für den USB-Ethernet-Adapter; Συμπληρωματικό εγχειρίδιο χρήσης Συσκευής επικοινωνίας LATITUDE™ για τον ασθενή Προσαρμογέας Ethernet USB; Apéndice del Manual del comunicador del paciente para el adaptador USB de Ethernet LATITUDE™; Supplément au Manuel patient du Communicateur LATITUDE™ pour l´adaptateur Ethernet USB; Supplemento al manuale per il paziente del Comunicatore LATITUDE™ relativo all'adattatore Ethernet USB; Aanvulling op de LATITUDE™ Communicator Patiëntenhandleiding voor de USB-ethernetadapter; Tillegg til pasienthåndbok for LATITUDE™-kommunikator – USB-Ethernet-adapter; Suplement do Instrukcji obsługi komunikatora LATITUDE™ dla pacjenta dotyczący adaptera USB do sieci Ethernet; Suplemento do Manual do Comunicador LATITUDE™ do Paciente para o Adaptador Ethernet USB; Doplnok k manuálu komunikátora LATITUDE™ pre pacienta – adaptér USB Ethernet; Bilaga om USB-Ethernet-adapter till LATITUDE™ kommunikator; LATITUDE™ Communicator - Patient Manual Supplement

  • FINELINE™ II

    Instructions for Use

    Cardiac Lead

    Mar 01, 2015

    Product Code 4456; 4457; 4458; 4459; 4479; 4480

    Part Number 355403-222

    Applicable To FINELINE™ II STEROX

    Safety Related Revision No

  • Q-TECH™ PROGRAMMER;EMBLEM™ S-ICD

    Programming Manuals

    PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHED; Q-TECH™ PROGRAMMIERGERÄT; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMMATEUR Q-TECH™; PROGRAMMATORE Q-TECH™; Q-TECH™ PROGRAMMER; PROGRAMADOR Q-TECH™; PROGRAMÁTOR Q-TECH™; Q-TECH™ PROGRAMMERINGSENHET

    Aug 01, 2014

    Product Code 3200

    Part Number 104749-005

    Applicable To SOUČÁST SYSTÉMU S-ICD®; EN DEL AF S-ICD®-SYSTEMET; EIN BESTANDTEIL DES S-ICD® SYSTEMS; A Component of the S-ICD® System; UN COMPONENTE DEL SISTEMA S-ICD®; COMPOSANT DU SYSTÈME S-ICD®; COMPONENTE DEL SISTEMA S-ICD®; EEN COMPONENT VAN HET S-ICD®-SYSTEEM; UM COMPONENTE DO SISTEMA S-ICD®; SÚČASŤ SYSTÉMU S-ICD®; EN KOMPONENT I S-ICD®-SYSTEMET

  • ZOOM™ LATITUDE™

    Supplemental Updates;Programming Manuals

    Programátor / záznamové zařízení / monitor ; Programmer/Recorder/Monitor; Programmier/Aufzeichnungs/Überwachungsgerät ; Προγραμματιστή/Καταγραφέα/Ελεγκτή; Programmer/Recorder/Monitor; programador/registrador/monitor; Programmateur/Enregistreur/Moniteur; Programozó/rekorder/monitor; Programmatore/Registratore/Monitor per l'operatore; Programmer/Recorder/Monitor; Programator/Rejestrator/Monitor; Programador/Registador/Monitor; programátora / nahrávacieho zariadenia / monitoru; Programmerare/Skrivare/Monitor; Programlayıcı/Kaydedici/Monitör; Programmer/Recorder/Monitor; Programmateur/Enregistreur/Moniteur; Programmerer/Opptaker/Monitor

    Jan 13, 2021

    Product Code 3120

    Part Number 359066-002

    Applicable To Secure Export Feature Enhancement; Secure Export Feature Enhancement; Amélioration de la Fonction d'Exportation Sécurisée; Zdokonalení funkce bezpečného exportu; Forbedring af sikker eksportfunktion; Erweiterung der sicheren Exportfunktion; Βελτίωση του Χαρακτηριστικού Ασφαλούς Εξαγωγής; Secure Export Feature Enhancement; Mejora de la función de exportación segura; Amélioration de la Fonction d'Exportation Sécurisée; A Biztonságos exportálás funkció bővítése; Miglioramento della funzione di esportazione sicura; Verbetering veilige exportfunctie; Forbedring i funksjonen for sikker eksportering; Rozbudowa funkcji Bezpieczny Eksport; Melhoria da Funcionalidade de Exportação Segura; Vylepšenie bezpečného exportu; Förbättring av funktionen för säker export; Secure Export Feature Enhancement; Güvenli Dışa Aktarma Özelliği Geliştirmesi

  • COGNIS™ 100-D CRT-D

    Reference Guides

    CARDIAC RESYNCHRONIZATION THERAPY HIGH ENERGY DEFIBRILLATOR

    Nov 13, 2012

    Product Code P106; P107; P108

    Part Number 357501-090

    Applicable To Note: This guide applies to pulse generators used in combination with programmers with software version 2.05 or greater.

  • LATITUDE™

    Clinician Manuals

    LATITUDE™ NXT Patient Management System

    May 01, 2014

    Product Code 6446; 6448

    Part Number 358827-020

    Safety Related Revision No

  • FINELINE™ II

    Instructions for Use

    Cardiac Lead

    Jun 21, 2022

    Product Code 4456; 4457; 4458; 4459; 4479; 4480

    Part Number 355403-222

    Applicable To FINELINE™ II STEROX

    Safety Related Revision No

  • IceRod™ 1.5 CX;IceSphere™ 1.5 CX;IceFORCE™ 2.1 CX;IcePearl™ 2.1 CX

    Instructions for Use

    Cryoablation Needle; Aguja para crioablación; Aiguille de cryoablation; Kryoablationsnadel; Ago per crioablazione; Cryoablatienaald; Agulha de Crioablação

    Jun 26, 2024

    Product Code H7493961435330; H7493961535730; H7493961836030; H7493970836080; H7493970636060; H7493961636010; H7493962036170; H7493961936040; H7493970736070; H7493970536050; H7493961736020; H7493962136180; H7493963936070; H7493963736050; H7493964036080; H7493963836060

    Part Number 51441619-01B

  • FARAWAVE™

    Instructions for Use

    Pulsed Field Ablation Catheter

    Jul 03, 2024

    Product Code M004PFCE41M401; M004PFCE41M402

    Part Number 51622663-01A

  • ZOOM™ LATITUDE™

    Programming Manuals

    Programmer/Recorder/Monitor

    Jul 17, 2024

    Product Code 3120

    Part Number 357435-150

    Safety Related Revision No

  • Seal™

    Instructions for Use

    Single Use Biopsy Valve; Válvula para biopsia de un solo uso; Valve de biopsie à usage unique; Biopsieventil für den einmaligen Gebrauch; Valvola monouso per biopsia; Biopsieklep voor eenmalig gebruik; Válvula de Biopsia de Uma Única Utilização

    Aug 26, 2024

    Product Code SBC-501-100, SBC-501

    Part Number 50676680-01B

    Applicable To Box 100

    Safety Related Revision Blank

  • LATITUDE™ Communicator

    Patient Information

    PATIENT MANUAL

    Aug 16, 2024

    Product Code 6288; 00802526617508; 6288; 00802526617423; 6288; 00802526577376; 6288; 00802526577383; 6288; 00802526616518; 6288; 00802526577413; 6288; 00802526617409; 6290; 00802526617805; 6290; 00802526617843; 6290; 00802526585678; 6290; 00802526585685; 6290; 00802526617812; 6290; 00802526585715; 6290; 00802526617829; 6290; 00802526617836; 6290; 00802526585739; 6290; 00802526606236; 6290; 00802526618918; 6290; 00802526606212

    Part Number 92435999-001

    Safety Related Revision No

  • Vercise™ PC;Vercise Gevia™;Vercise Neural Navigator™;Vercise Genus™;Vercise™ Cartesia™;SureTek™

    Instructions for Use

    Deep Brain Stimulation System

    Feb 02, 2022

    Product Code DB-1216, DB-1232, DB-1416, DB-1432, DB-1200, DB-1140, DB-2201-30-DC, DB-2201-45-DC, DB-2201-30-AC, DB-2201-45-BC, DB-2202-30, DB-2202-45, DB-4600-C, NM-3138-55, DB-3128-55, DB-3128-95, DB-9418-15, DB-9218-15, DB-9218-55, DB-5170, DB-5132, DB-9315, DB-4120-08, DB-4100-A, SC-4100-A, DB-2500-C, DB-4605-C, SC-4401, SC-4252, DB-4252, SC-4254, DB-4254, DB-5572-1A, DB-5250, DB-5552-1A, DB-5250, DB-5542-1A, DB-5240, DB-64125, DB-64126, NM-6210, DB-6315, NM-6315, NM-6310, NM-6600, DB-6300-C, DB-6200-C, DB-6100-C, NM-6358-SP0, DB-6358-0BK, DB-6358-1BK, DB-6358-5BK, DB-6358-9BK, NM-6350, NM-5312, NM-5305, NM-6305, DB-7164, NM-7164, DB-7164-R, NM-7164-R, DB-7105-N4A, DB-6386, DB-7190, NM-7190, NM-6316, NM-7165, NM-7171

    Part Number 92366226-07 Rev A

    Applicable To Vercise™ DBS Systems - Information for Prescribers

    Safety Related Revision No

  • Vercise™ PC;Vercise Gevia™;Vercise Neural Navigator™

    Installation Guide

    Neural Navigator 2 Programming Software

    Feb 25, 2021

    Product Code DB-7161; DB-7161-R; NM-7161; NM-7161-R; DB-7105-N2

    Part Number 91155463-02 A

    Applicable To Vercise™ Neural Navigator 2 Installation Guide

    Safety Related Revision No

  • OMG™ Adapter

    Instructions for Use

    Adapter

    Sep 11, 2018

    Product Code SC-9315

    Part Number 92089844-02 A

    Applicable To Precision Spectra™ OMG™ Adapter

    Safety Related Revision No

  • Precision™

    Instructions for Use

    SCS System

    Feb 27, 2015

    Product Code SC-1110; SC-2016; SC-2138; SC-2158; SC; 2208; ; SC-2218; SC-2316; SC-2352; SC-2366; SC-3138; SC-3304; SC-3354; SC-3400; SC-5210; SC-5212; SC-5305; SC-5312; ; SC-8216; SC-8120

    Part Number 90719336-01B

    Applicable To Pautas sobre la realización de RMN de 1,5 teslas para el sistema de estimulación de la médula espinal Precision™

    Safety Related Revision No

  • VISUAL-ICE™

    Operator's Manual

    Cryoablation System; Dual Cylinder Adapter; Sistema de crioablación; Adaptador para dos cilindros; Système de cryoablation; Adaptateur pour deux bouteilles; Kryoablationssystem; Adapter für Dual-Zylinder; Sistema di crioablazione; Adattatore 2 in 1 per due bombole; Cryoablatiesysteem; Adapter voor dubbele cilinder; Sistema de Crioablação; Adaptador para Duas Botijas

    Jun 13, 2024

    Product Code H7493960960000; H74939609D60000; H74939609H60000; H74939609R60000; H74939609Z60000; FPRCH4005; FPRCH4008; FPRCH6143; FPRCH6146

    Part Number 51342550-01A

  • IceSphere™ 1.5;IceRod™ 1.5;IceSeed™ 1.5

    Instructions for Use

    Cryoablation Needle

    Jul 27, 2023

    Product Code FPRPR3008: FPRPR3070; FPRPR3570; FPRPR3571; FPRPR3572; FPRPR3605; FPRPR3606; FPRPR3607; FPRPR3608; FPRPR4070; FPRPR4518; FPRPR4009; FPRPR3201; FPRPR3202; FPRPR3203; FPRPR3204; FPRPR3258; FPRPR3260; FPRPR3508; FPRPR3510; FPRPR3558; FPRPR3560; FPRPR3561

    Part Number LGC20-NDL105 Rev. 01

    Safety Related Revision No

  • ICEfx™ Cryoablation System

    Operator's Manual

    Cryoablation System; Cart; Dual Cylinder Adapter; Sistema de crioablación; Carro; Adaptador para dos cilindros; Système de cryoablation; Chariot; Adaptateur pour deux bouteilles; Kryoablationssystem; Wagen; Adapter für Dual-Zylinder; Sistema di crioablazione; Carrello; Adattatore 2 in 1 per due bombole; Cryoablatiesysteem; Wagentje; Adapter voor dubbele cilinder; Sistema de Crioablação; Carrinho; Adaptador para Duas Botijas

    Jun 13, 2024

    Product Code H749396118000; H74939611D8000; H74939611H8000; H74939611R8000; H74939611Z8000; FPRCH4005; FPRCH4008; FPRCH6143; FPRCH6146; FPRCH8010

    Part Number 51217944-01B

  • AMS 800™ Urinary Control System

    Instructions for Use

    Sistema de controlo urinário para doentes do sexo feminino e pediátricos

    May 01, 2017

    Product Code 72404127; 72400023; 72400024; 72400025; 720157‐01; 72404130; 72404131; 72404132; 72404133; 72404134; 72404135; 72404136; 72404137; 72404138; 72404140; 72404142; 72404144; 720133-01; 72400160; 72400161; 72400162; 72400163; 72400164; 72400165; 72400166; 72400167; 72400168; 72400170; 72400172; 72400174; 72400098; 720066‐01; 72401685

    Part Number 92116965-01A

    Safety Related Revision No

  • rezūm™

    Instructions for Use

    Delivery Device Kit for BPH

    Apr 22, 2021

    Product Code D2201-003

    Part Number 3032-004

  • CXR™ Rear Tip Extender Kit

    Instructions for Use

    Gamme de prothèses péniennes; Linha de produtos de próteses penianas; Linea di protesi peniene; Línea de prótesis de pene

    Jul 01, 2016

    Product Code 72403872, 72404320, 72404321, 72404322, 72404323, 72404330

    Part Number 230129-01_C

    Safety Related Revision No

  • AMS Ambicor™ Penile Prosthesis

    Instructions for Use

    Prothèse pénienne gonflable; Auffüllbares Schwellkörperimplantat; Prótese Peniana Insuflável; Prótesis de pene inflable; Protesi peniena gonfiabile

    Nov 01, 2016

    Product Code 72401450; 72401451; 72401452; 72401453; 72401454; 72401455; 72401456; 72401457; 72401458

    Part Number 230119-01E

  • AMS 800™ Urinary Control System

    Instructions for Use

    Urinary Control System For Male Patients; Système de contrôle urinaire pour les hommes; Sistema de control urinario para varones; Sistema de controlo urinário para doentes do sexo masculino; System zur Blasenkontrolle für den Mann; Sistema di controllo urinario per pazienti maschi

    May 01, 2017

    Product Code 72404127; 72400023; 72400024; 72400025; 720157‐01; 72404130; 72404131; 72404132; 72404133; 72404134; 72404135; 72404136; 72404137; 72404138; 72404140; 72404142; 72404144; 720133-01; 72400160; 72400161; 72400162; 72400163; 72400164; 72400165; 72400166; 72400167; 72400168; 72400170; 72400172; 72400174; 72400098; 720066‐01; 72401685

    Part Number 92116966-01A

    Safety Related Revision No

  • Disposable Dilators

    Instructions for Use

    Disposable Dilator; Dilatateur jetable; Dilatador desechable; Dilatador Descartável

    Sep 01, 2017

    Product Code 720117-01

    Part Number 92130122-01A

    Safety Related Revision No

  • AMS 700™ with MS Pump™

    Instructions for Use

    Penile Prosthesis Product Line; Productlijn penisprothesen; Penisprotesproduktsortiment; Linha de produtos de próteses penianas; Linea di prodotti di protesi peniene; Línea de prótesis de pene; Produktreihe der Schwellkörperimplantate; Gamme de prothèses péniennes

    Aug 01, 2017

    Product Code 72404250; 72404251; 72404252; 72404253; 72404255; 72404256; 72404257; 72040258; 72404252-10; 72404253-12; 72404300; 72404301; 72404302; 72404303; 72404305; 72404306; 72404307; 72404308; 72404302-10; 72404303-12; 72404241; 72404242; 72404243; 72404244; 72404291; 72404292; 72404293; 72404294; 72404230; 72404231; 72404232; 72404233; 72404234; 72404235; 72404236; 72404237; 72404238; 72404239; 72404232‐10; 72404233‐12; 72404234‐14; 72404280; 72404281; 72404282; 72404283; 72404284; 72404285; 72404286; 72404287; 72404288; 72404289; 72404282-10; 72404283-12; 72404284-14; 72404171; 72404172; 72404173; 72404174; 72404175; 72404271; 72404272; 72404273; 72404274; 72404275; 72404260; 72404261; 72404262; 72404263; 72404264; 72404265; 72404266; 72404267; 72404268; 72404269; 72404010; 72404011; 72404012; 72404013; 72404014; 72403872; 720185‐01; 72400095; 72404155; 72404156; 72404209; 72404161; 72404162; 72404310; 72401850; 72404043; 720182-01; 72404320; 72404321; 72404322; 72404323; 72404324; 72404325; 72404326; 72404330

    Part Number 92162915-01A

    Safety Related Revision No

  • Ambicor™

    Instructions for Use

    Inflatable Penile Prosthesis; Prótesis de pene inflable; Prothèse pénienne gonflable; Prótese Peniana Insuflável

    Nov 01, 2019

    Product Code 72401450, 72401451, 72401452, 72401453, 72401454, 72401455, 72401456, 72401457, 72401458, 72402890

    Part Number 50654573-01B

    Safety Related Revision No

  • AMS 800™ Urinary Control System

    Instructions for Use

    Artificial Urinary Sphincter; Esfínter urinario artificial; Sfintere urinario artificiale; Sphincter urinaire artificiel; Künstlicher Blasenschließmuskel; Esfíncter urinário artificial

    Feb 01, 2017

    Product Code 72404127; 72400023; 72400024; 72400025; 720157‐01; 72404130; 72404131; 72404132; 72404133; 72404134; 72404135; 72404136; 72404137; 72404138; 72404140; 72404142; 72404144; 720133-01; 72400160; 72400161; 72400162; 72400163; 72400164; 72400165; 72400166; 72400167; 72400168; 72400170; 72400172; 72400174; 72400098; 720066‐01; 72401685

    Part Number 1003182A

    Applicable To For Female and Pediatric Patients; Para mujeres y niños; Per pazienti femmine e pediatrici; Pour les femmes et les enfants; Für Frauen und Kinder; Para doentes do sexo feminino e pediátricos

  • AMS 800™ Urinary Control System

    Programming Manuals

    Urinary Control SystemFor Male, Female, and Pediatric Patients

    May 01, 2017

    Product Code 72400023, 72400024. 72400025, 72400098, 72400160, 72400161, 72400162, 72400163, 72400164, 72400165, 72400166, 72400167, 72400168, 72400170, 72400172, 72400174, 72401685, 72404127, 72404130, 72404131, 72404132, 72404133, 72404134, 72404135, 72404136, 72404137, 72404138, 72404140, 72404142, 72404144, 720066-01, 720133-01, 720157-01

    Part Number 92116967-01A

    Safety Related Revision No

  • AMS 800™ Urinary Control System

    Instructions for Use

    Artificial Urinary Sphincter; Esfíncter urinário artificial; Sphincter urinaire artificiel; Esfínter urinario artificial; Künstlicher Blasenschließmuskel; Sfintere urinario artificiale

    Feb 01, 2017

    Product Code 72404127; 72400023; 72400024; 72400025; 720157‐01; 72404130; 72404131; 72404132; 72404133; 72404134; 72404135; 72404136; 72404137; 72404138; 72404140; 72404142; 72404144; 720133-01; 72400160; 72400161; 72400162; 72400163; 72400164; 72400165; 72400166; 72400167; 72400168; 72400170; 72400172; 72400174; 72400098; 720066‐01; 72401685

    Part Number 1003181A

    Applicable To For Male Patients; Para doentes do sexo masculino; Pour les hommes; Para varones; Für den Mann; Per pazienti maschi

  • AMS 800™ Urinary Control System

    Programming Manuals

    Artificial Urinary Sphincter

    Jul 01, 2016

    Product Code 72404127; 72400023; 72400024; 72400025; 720157‐01; 72404130; 72404131; 72404132; 72404133; 72404134; 72404135; 72404136; 72404137; 72404138; 72404140; 72404142; 72404144; 720133-01; 72400160; 72400161; 72400162; 72400163; 72400164; 72400165; 72400166; 72400167; 72400168; 72400170; 72400172; 72400174; 72400098; 720066‐01; 72401685

    Part Number 1002533B

    Applicable To For Male, Female, and Pediatric Patients

  • AMS Ambicor™ Penile Prosthesis

    Instructions for Use

    Penile Prosthesis; Prothèse pénienne; Prótesis de pene; Prótese Peniana; Protesi peniena; Schwellkörperimplantat

    Aug 01, 2017

    Product Code 72401450, 72401451, 72401452, 72401453, 72401454, 72401455, 72401456, 72401457, 72401458, 72402890

    Part Number 92113093-01A

    Safety Related Revision No

  • Disposable Dilators

    Instructions for Use

    Einweg-Dilatator; Dilatateur jetable; Dilatador desechable; Dilatatore monouso; Disposable Dilator; Dilatador Descartável

    Nov 01, 2016

    Product Code 720117-01

    Part Number 230118-01D

  • Disposable Dilators

    Instructions for Use

    Disposable Dilator; Einweg-Dilatator; Dilatador desechable; Dilatateur jetable; Dilatatore monouso; Dilatador Descartável

    Apr 08, 2021

    Product Code 720131-01; 720117-01

    Part Number 92130122-01B

    Applicable To CE 2797 Legal Manufacturer—AMS; CE 2797 Berechtigter Hersteller—AMS; CE 2797 Fabricante legal—AMS; CE 2797 Fabricant légal—AMS; CE 2797 Fabbricante legale—AMS; CE 2797 Fabricante Legal—AMS

    Safety Related Revision No

  • rezūm™

    Instructions for Use

    Generator

    Apr 22, 2021

    Product Code G2200-0031

    Part Number 3033-001

  • AMS™ Quick Connect Assembly Tool

    Instructions for Use

    Sistema de Conexão Rápida sem Sutura; Système de connexion rapide (sans fil); Nahtlose Schnellkonnektoren mit Fenster; Conectores rápidos sin sutura; Conectores rápidos sin sutura; Connettori rapidi a finestra

    Nov 01, 2016

    Product Code 72400023, 72400024, 72400025, 72400095, 72400098, 72400160, 72400161, 72400162, 72400163, 72400164, 72400165, 72400166, 72400167, 72400168, 72400170, 72400172, 72400174, 72401685, 72401850, 72404010, 72404011, 72404012, 72404013, 72404014, 72404127, 72404130, 72404131, 72404132, 72404133, 72404134, 72404135, 72404136, 72404137, 72404138, 72404140, 72404142, 72404144, 72404155, 72404156, 72404161, 72404162, 72404171, 72404172, 72404173, 72404174, 72404175, 72404209, 72404230, 72404231, 72404232, 72404233, 72404234, 72404235, 72404236, 72404237, 72404238, 72404239, 72404241, 72404242, 72404243, 72404244, 72404250, 72404251, 72404252, 72404253, 72404255, 72404256, 72404257, 72404258, 72404260, 72404261, 72404262, 72404263, 72404264, 72404265, 72404266, 72404267, 72404268, 72404269, 72404271, 72404272, 72404273, 72404274, 72404275, 72404280, 72404281, 72404282, 72404283, 72404284, 72404285, 72404286, 72404287, 72404288, 72404289, 72404291, 72404292, 72404293, 72404294, 72404300, 72404301, 72404302, 72404303, 72404305, 72404306, 72404307, 72404308, 72404310, 720133-01, 720157-01, 720182-01, 720185-01, 72404232-10, 72404233-12, 72404234-14, 72404252-10, 72404253-12, 72404282-10, 72404283-12, 72404284-14, 72404302-10, 72404303-12

    Part Number 230128-01_C

    Safety Related Revision No

  • rezūm™

    Instructions for Use

    Delivery Device Kit for BPH; Kit dispositivo di rilascio per BPH; Kit de dispositif de mise en place pour BPH; Kit do Dispositivo de Administração para BPH; Applikationssystemsatz für BPH; Kit de dispositivo de introducción para BPH; Plaatsingsinstrument voor BPH

    May 23, 2022

    Product Code D2201

    Part Number 50966794-01A

  • AutoCap™ RX

    Instructions for Use

    Integrated Biopsy Cap and Guidewire Locking Device; Dispositivo integrado de bloqueo de guía y tapa para biopsias; Dispositif de verrouillage du guide et capuchon de biopsie intégré; Führungsdraht-Sperrvorrichtung mit integriertem Biopsieverschluss; Tappo per biopsia e dispositivo di bloccaggio del filoguida integrati; Geïntegreerde biopsiedop en vergrendelingshulpmiddel voor de voerdraad; Tampa para Biopsia Integrada e Dispositivo de Bloqueio do Fio-guia

    Jun 13, 2024

    Product Code M00545100; M00545101; M00545130; M00545131

    Part Number 51474204-01Rev.A

  • Agile™ Esophageal

    MRI Information;Instructions for Use

    Partially Covered OTW Stent System; Partially Covered OTW Sistema de stent; Partially Covered OTW Système de stent; Partially Covered OTW Stentsystem; Partially Covered OTW Sistema stent; Partially Covered OTW Stentsysteem; Partially Covered OTW Sistema de stent

    Jul 12, 2022

    Product Code M00517710; M00517720; M00517730; M00517740

    Part Number 51095565-01A

  • Agile™ Esophageal

    MRI Information;Instructions for Use

    Fully Covered RMV OTW Stent System; Fully Covered RMV OTW Sistema de stent; Fully Covered RMV OTW Système de stent; Fully Covered RMV OTW Stentsystem; Fully Covered RMV OTW Sistema stent; Fully Covered RMV OTW Stentsysteem; Fully Covered RMV OTW Sistema de stent

    Jul 12, 2022

    Product Code M00517790; M00517800; M00517810; M00517820

    Part Number 51252996-01A

  • RX Locking Device

    Instructions for Use

    Locking Device For Use with RX Biliary System™, Dispositivo de bloqueo para utilizarse con el RX Biliary System™, Dispositif de verrouillage à utiliser avec RX Biliary System™, Sperrvorrichtung zur Verwendung mit RX Biliary System™, Dispositivo di bloccaggio per l’uso con RX Biliary System™, Borginstrument voor gebruik met het RX Biliary System™, Dispositivo de Bloqueio para Utilização com o RX Biliary System™

    Sep 20, 2022

    Product Code M00545211, M0054210

    Part Number 51088990-01A

    Applicable To Box 10

  • Agile™ Esophageal

    MRI Information;Patient Information

    Fully Covered RMV OTW Stent System

    Feb 12, 2024

    Product Code M00517790; M00517800; M00517810; M00517820

    Part Number 51396245-01A

    Safety Related Revision Blank

  • Agile™ Esophageal

    MRI Information;Patient Information

    Fully Covered OTW Stent System

    Feb 12, 2024

    Product Code M00517750; M00517760; M00517770; M00517780

    Part Number 51396244-01A

    Safety Related Revision Blank

  • Koala™

    Instructions for Use

    Cleaning Sponge plus Pure™ Enzymatic; Esponja de limpieza y detergente enzimático Pure™; Éponges nettoyante imprégnée de détergent enzymatique Pure™; Reinigungsschwamm plus Pure™-Enzymreiniger; Spugna per pulizia con soluzione enzimatica Pure™; Reinigingssponsje met Pure™ enzymatisch reinigingsmiddel; Rengøringssvamp med Pure™-enzymrengøringsmiddel; Σπόγγος καθαρισμού συν ενζυματικό Pure™; Esponja de Limpeza com Solução Enzimática Pure™; Rengöringssvamp och Pure™ enzymatiskt rengöringsmedel; Törlőszivacs Pure™ enzimatikus anyaggal; Čisticí houbička s enzymatickým roztokem Pure™ Enzymatic; Czyszczenie Sponge plus Pure™ Enzymatic; Rengjøringssvamp plus Pure™ enzymatisk; Puhdistussieni ja entsymaattinen Pure™-pesuaine; Burete de curățare plus Pure™, enzimatic; Čistiaca špongia s enzymatickým prípravkom Pure™; Почистваща гъба плюс детергент Pure™ Enzymatic; Spužva za čišćenje s enzimskim sredstvom Pure™; Ensümaatiline puhastuskäsn Pure™; Fermentatīvs tīrīšanas sūklis plus Pure™; Valymo kempinė Plus „Pure™ Enzymatic“; Čistilna gobica plus encimsko čistilo Pure™

    Dec 08, 2021

    Product Code SES-240-50

    Part Number 51096726-01A

    Applicable To Box 50

    Safety Related Revision Blank

  • Agile™ Esophageal

    MRI Information;Patient Information

    Partially Covered OTW Stent System

    Feb 12, 2024

    Product Code M00517710, M00517720, M00517730, M00517740

    Part Number 51396243-01A

    Safety Related Revision Blank

  • Agile™ Esophageal

    MRI Information;Instructions for Use

    Fully Covered RMV Stent System; Fully Covered RMV Sistema de stent; Fully Covered RMV Système de stent; Fully Covered RMV Stentsystem; Fully Covered RMV Sistema di stent; Fully Covered RMV Stentsysteem; Fully Covered RMV Sistema de Stent

    Jul 22, 2022

    Product Code M00517580; M00517590; M00517600; M00517610; M00517620; M00517630; M00517640; M00517650

    Part Number 51416368-01A

    Safety Related Revision No

  • Agile™ Esophageal

    MRI Information;Instructions for Use

    Fully Covered OTW Stent System; Fully Covered OTW Sistema de stent; Fully Covered OTW Système de stent; Fully Covered OTW Stentsystem; Fully Covered OTW Sistema stent; Fully Covered OTW Stentsysteem; Fully Covered OTW Sistema de stent

    Jul 12, 2022

    Product Code M00517750; M00517760; M00517770; M00517780

    Part Number 51252995-01A

  • Agile™ Esophageal

    MRI Information;Instructions for Use

    Fully Covered Stent System; Fully Covered Sistema de stent; Fully Covered Système de stent; Fully Covered Stentsystem; Fully Covered Sistema di stent; Fully Covered slokdarmstentsysteem; Fully Covered Sistema de Stent

    Jul 22, 2022

    Product Code M00517400; M00517410; M00517420; M00517430; M00517440; M00517450; M00517460; M00517470

    Part Number 51416367-01A

    Safety Related Revision No

  • Agile™ Esophageal

    MRI Information;Instructions for Use

    Partially Covered Stent System; Partially Covered Sistema de stent; Partially Covered Système de stent; Partially Covered Stentsystem; Partially Covered Sistema di stent; Partially Covered slokdarmstentsysteem; Partially Covered Sistema de Stent

    Jul 22, 2022

    Product Code M00517200; M00517210; M00517220; M00517230; M00517240; M00517250; M00517260; M00517270

    Part Number 51416369-01A

    Safety Related Revision No

  • RHYTHMIA HDx™

    Instructions for Use

    Mapping System

    Aug 16, 2023

    Product Code M004RA5010A0; M004RA5010I0; M004RA5110A0; M004RA5110I0; M004RA9000ECG30; M004RA9000ECG60; M004RA9000ICAB30; M004RA9000ICAB60; M004RA9000ICM30; M004RA9000ICM60; M004RA9100ECG30; M004RA9100ECG60; M004RA9100IC30; M004RA9100IC60; M004RALRCBL20; M004RAMMTIPS220; M004RH11120; M004RH11220; M004RH15010; M004RA71010; M004RBEVAL2END0; M004RH10200; M004RH1020H0; M004RH1020R0; M004RH20010; M004RH20020; M004RH40100; M004RH14010; M004RH14510; M004RA60010; M004RA62010; M004RH11020; M004RBINSTALL2EN0; 1964-01; 1964-00; 1963-01; 1963-00; 1962-00; 1962-01; 1961-00; 1961-01; 1945-00; 1945-01; 1944-00; 1944-01; 2064-00; 2064-01; 1964-02; 1943-00; 1943-01; 1942-01; 1941-01; 1940-00; 1940-01; 1939-00; 1939-01; 1964-04; 1943-04; 1943-03

    Part Number 51124867-01A

  • Acquire™ S

    Instructions for Use

    Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device; Dispositivo de biopsia con aguja fina (FNB) por ecografía endoscópica; Dispositif de biopsie par aiguille fine (BAF) sous échoendoscopie; Vorrichtung zur endoskopischen Ultraschall-Feinnadelbiopsie (FNB); Dispositivo di aspirazione con ago sottile per biopsia endoscopica a ultrasuoni (FNB); Hulpmiddel voor ultrasone endoscopische fijnenaaldbiopsie (FNB); Dispositivo de Biopsia por Agulha Fina (FNB) para Ecografia Endoscópica

    Sep 05, 2024

    Product Code M00555660; M00555661; M00555640; M00555641

    Part Number 51648291-01A

  • MDU5 PLUS™ Sterile Bag ;OptiCross™ 6 HD;OptiCross™ HD

    Instructions for Use

    60 MHz Coronary Imaging Catheters; Catéteres para toma de imágenes coronarias de 60 MHz; Cathéters d'imagerie coronarienne 60 MHz; 60 MHz Koronar-Bildgebungskatheter; Cateteri per imaging coronarico da 60 MHz; 60 MHz coronaire echografiekatheters; Cateteres Ecográficos Coronários de 60 MHz Sterile Bag for MDU5 PLUS Motordrive Unit; Bolsa estéril para unidad motora MDU5 PLUS; Poche stérile pour unité d’entraînement à moteur MDU5 PLUS; Steriler Beutel für MDU5 PLUS Motorantriebseinheit; Sacchetto sterile per unità di azionamento MDU5 PLUS; Steriele zak voor MDU5 PLUS-motoraandrijfeenheid; Bolsa Esterilizada da Unidade de Acionamento do Motor MDU5 PLUS

    Sep 12, 2024

    Product Code H74939352020; H74939352030; H74939354060; H74939354070

    Part Number 51393430-01B

  • LATITUDE™

    Integration Guides

    LATITUDE INTEGRATION IDCO SPECIFICATION; LATITUDE Patient Management System

    Sep 27, 2024

    Product Code 6455; 6624; 6446; 6448; 6460

    Part Number 92290289-001

    Safety Related Revision No

  • LATITUDE™

    Clinician Manuals;Integration Guides

    LATITUDE NXT Patient Management System

    Sep 27, 2024

    Product Code 6455; 6624; 6446; 6448; 6460

    Part Number 92290311-001

    Applicable To LATITUDE™ NXT- LATITUDE INTEGRATION HL7 SPECIFICATION

  • LUX-Dx™

    Instructions for Use

    LUX-Dx™ Insertable Cardiac Monitor System

    Sep 27, 2024

    Product Code M301; 2925; 2935; 7246

    Part Number 92216690-001

  • LUX-Dx™

    MRI Information

    IMAGEREADY™ MR Conditional ICM System

    Sep 27, 2024

    Product Code M301

    Part Number 92216913-001

  • LUX-Dx™

    Instructions for Use

    LUX-Dx™ Insertable Cardiac Monitor System

    Sep 27, 2024

    Product Code M301; 2925; 2935; 7246

    Part Number 51676508-001

  • LATITUDE™ NXT

    Clinician Manuals

    LATITUDE NXT Patient Management System

    Sep 27, 2024

    Product Code 6288; 6290; 6446; 6468; 6496

    Part Number 51467383-001

    Safety Related Revision No

  • OverStitch™ Suture Cinch;OverStitch™ Endoscopic Suturing System;OverStitch™ 2-0 Polypropylene Sature;OverStitch™ Tissue Helix

    Instructions for Use

    Endoscopic Suturing System; Система за ендоскопско съшиване; sustav za endoskopsko šivanje; Systém pro endoskopické šití; Endoskopisk sutureringssystem; Endoscopisch hechtsysteem; Endoskoopiline haavaõmblemise süsteem; Endoskooppinen ommeljärjestelmä; Système de suture endoscopique; Endoskopisches Fadensystem; Σύστημα ενδοσκοπικής συρραφής; Endoszkópos varrórendszer; Sistema di sutura endoscopico; Endoskopiskā šuvju uzlikšanas sistēma; Endoskopinė siuvimo sistema; Endoskopisk sutureringssystem; System do endoskopowego zakładania szwów; Sistema de sutura endoscópica; Systém na endoskopické šitie; Endoskopski sistem za suturo; Sistema de sutura endoscópico; Endoskopiskt sutursystem; Endoskopik Sütür Sistemi Polypropylene Suture; Полипропиленов конец; polipropilenski kirurški konac; Polypropylénová sutura; Polypropylensutur; Polypropyleen hechtdraad; Polüpropüleenist haavaõmblus; Polypropeeniommel; Suture en polypropylène; Polypropylenfaden; Ράμμα πολυπροπυλενίου; Polipropilén varrat; Sutura in polipropilene; Polipropilēna šuve; Polipropileno siūlas; Polypropylensutur; Szew polipropylenowy; Sutura de polipropileno; Polypropylénový šijací materiál; Polipropilenska sutura; Sutura de polipropileno; Polypropylensutur; Polipropilen Sütür Suture Cinch; Структура на съшиване; cinch za zatezanje šavova; Sutura Cinch; Sutur Cinch; Hecht-cinch; Õmbluse pinguti; Ommellangan kiristin; Tenseur de suture; Faden-Cinch; Συγκρατητήρας ραμμάτων; Cinch varrat; Cinch per sutura; Šuves stiprinājums; Siūlo spaustukas; Suturfeste; Cinch do zakładania szwów; Cinta de Sutura; Šijací materiál na uzatváranie; Zategnjena sutura; Ajuste de sutura; Cinch-sutur; Sütür Kancası Tissue HeliX; Тъкан HeliX; spirala za zahvaćanje tkiva; Tkáň HeliX; Vævshelix; Weefsel-HeliX; Koe HeliX; Kudos HeliX; Préhenseur hélicoïdal pour tissus Tissue HeliX; Gewebe-Helix; Έλικα ιστού; Szövet HeliX; Tessuto HeliX; Audu paņemšanas spirālveida ierīce; „HeliX“ audinys; HeliX til vev; HeliX do tkanek; Tecido HeliX; HeliX na tkanivo; Tkivna vijačnica; Tejido HeliX; Vävnads-HeliX; Doku Heliksi

    Oct 09, 2024

    Product Code 10811955020664; ESS-G02-160; 00811955020735; PLY-G02-020-APL; CNH-G01-000; 10811955020671; THX-165-028; 10811955020688

    Part Number GRF-00553-00R01

    Applicable To OverStitch Sutures are associated with 3 different products OverStitch, OverStitch Sx, and Overstitch NXT.; OverStitch Suture Cinch is associated with 4 different products OverStitch, OverStitch Sx, Overstitch NXT. and X-Tack.; Suture have a standalone IFU but the user should still reverence the OverStitch, Sx, or NXT IFU for use context.

  • OverStitch™ Suture Cinch;OverStitch Sx™ Endoscopic Suturing System;OverStitch™ 2-0 Polypropylene Sature;OverStitch™ Tissue Helix

    Instructions for Use

    Endoscopic Suturing System; Система за ендоскопско съшиване; sustav za endoskopsko šivanje; Systém pro endoskopické šití; Endoskopisk sutureringssystem; Endoscopisch hechtsysteem; Endoskoopiline haavaõmblemise süsteem; Endoskooppinen ommeljärjestelmä; Système de suture endoscopique; Endoskopisches Fadensystem; Σύστημα ενδοσκοπικής συρραφής; Endoszkópos varrórendszer; Sistema di sutura endoscopico; Endoskopiskā šuvju uzlikšanas sistēma; Endoskopinė siuvimo sistema; Endoskopisk sutureringssystem; System do endoskopowego zakładania szwów; Sistema de sutura endoscópica; Sistem de suturare endoscopic; Systém na endoskopické šitie; Endoskopski sistem za suturo; Sistema de sutura endoscópico; Endoskopiskt sutursystem; Endoskopik Sütür Sistemi; Polypropylene Suture; Полипропиленов конец; polipropilenski kirurški konac; Polypropylénová sutura; Polypropylensutur; Polypropyleen hechtdraad; Polüpropüleenist haavaõmblus; Polypropeeniommel; Suture en polypropylène; Polypropylenfaden; Ράμμα πολυπροπυλενίου; Polipropilén varrat; Sutura in polipropilene; Polipropilēna šuve; Polipropileno siūlas; Polypropylensutur; Szew polipropylenowy; Sutura de polipropileno; Sutură din polipropilenă; Polypropylénový šijací materiál; Polipropilenska sutura; Sutura de polipropileno; Polypropylensutur; Polipropilen Sütür; Suture Cinch; Структура на съшиване; cinch za zatezanje šavova; Sutura Cinch; Sutur Cinch; Hecht-cinch; Õmbluse pinguti; Ommellangan kiristin; Tenseur de suture; Faden-Cinch; Συγκρατητήρας ραμμάτων; Cinch varrat; Cinch per sutura; Šuves stiprinājums; Siūlo spaustukas; Suturfeste; Cinch do zakładania szwów; Cinta de Sutura; Sutură Cinch; Šijací materiál na uzatváranie; Zategnjena sutura; Ajuste de sutura; Cinch-sutur; Sütür Kancası; Tissue HeliX; Тъкан HeliX; spirala za zahvaćanje tkiva; Tkáň HeliX; Vævshelix; Weefsel-HeliX; Koe HeliX; Kudos HeliX; Préhenseur hélicoïdal pour tissus Tissue HeliX; Gewebe-Helix; Έλικα ιστού; Szövet HeliX; Tessuto HeliX; Audu paņemšanas spirālveida ierīce; „HeliX“ audinys; HeliX til vev; HeliX do tkanek; Tecido HeliX; Țesut HeliX; HeliX na tkanivo; Tkivna vijačnica; Tejido HeliX; Vävnads-HeliX; Doku Heliksi

    Oct 09, 2024

    Product Code 10811955020718; ESS-G02-Sx1; 00811955020735; PLY-G02-020-APL; CNH-G01-000; 10811955020671; THX-165-028; 10811955020688

    Part Number GRF-00554-00R01

  • OverStitch™ 2-0 Polypropylene Sature

    Instructions for Use

    Polypropylene Suture; Полипропиленов конец; polipropilenski kirurški konac; Polypropylénová sutura; Polypropylensutur; Polypropyleen hechtdraad; Polüpropüleenist haavaõmblus; Polypropeeniommel; Suture en polypropylène; Polypropylenfaden; Ράμμα πολυπροπυλενίου; Polipropilén varrat; Sutura in polipropilene; Polipropilēna šuve; Polipropileno siūlas; Polypropylensutur; Szew polipropylenowy; Sutura de polipropileno; Sutură din polipropilenă; Sutura de polipropileno; Polypropylénový šijací materiál; Polipropilenska sutura; Polypropylensutur; Polipropilen Sütür

    Oct 11, 2024

    Product Code 00811955020735; PLY-G02-020-APL

    Part Number GRF-00555-00R01

  • OverTube™ Endoscopic Access System

    Instructions for Use

    Endoscopic Access System; Система за ендоскопски достъп; Systém pro endoskopický přístup; Endoskopisk adgangssystem; Endoskopisches Zugangssystem; Σύστημα ενδοσκοπικής πρόσβασης; Sistema de acceso endoscópico; Endpskoopiline ligipääsu süsteem; Endoskooppinen sisäänvientijärjestelmä; Système d'accès endoscopique; sustav za endoskopski pristup; Endoszkópos hozzáférési rendszer; Sistem Akses Endoskopi; Holspeglunaraðgangskerfi; Sistema di accesso endoscopico; 内視鏡アクセスシステム; 내시경 접근 시스템; Endoskopinės prieigos sistema; Endoskopiskā piekļuves sistēma; Endoskopisk tilgangssystem; Endoscopisch toegangssysteem; System dostępu endoskopowego; Sistema de acesso endoscópico; Sistema de acesso endoscópico; Sistem de acces endoscopic; Система для эндоскопического доступа; Systém na endoskopický prístup; Endoskopski sistem za dostop; Endoskopiskt åtkomstsystem; Endoskopik Erişim Sistemi; Система ендоскопічного доступу; 内窥镜接入系统

    Oct 11, 2024

    Product Code 10811955020701; OVT-027-160

    Part Number GRF-00081-00R10

  • OverTube™ Endoscopic Access System

    Instructions for Use

    Endoscopic Access System; Система за ендоскопски достъп; Systém pro endoskopický přístup; Endoskopisk adgangssystem; Endoskopisches Zugangssystem; Σύστημα ενδοσκοπικής πρόσβασης; Sistema de acceso endoscópico; Endpskoopiline ligipääsu süsteem; Endoskooppinen sisäänvientijärjestelmä; Système d'accès endoscopique; sustav za endoskopski pristup; Endoszkópos hozzáférési rendszer; Sistem Akses Endoskopi; Holspeglunaraðgangskerfi; Sistema di accesso endoscopico; 内視鏡アクセスシステム; 내시경 접근 시스템; Endoskopinės prieigos sistema; Endoskopiskā piekļuves sistēma; Endoskopisk tilgangssystem; Endoscopisch toegangssysteem; System dostępu endoskopowego; Sistema de acesso endoscópico; Sistema de acesso endoscópico; Sistem de acces endoscopic; Система для эндоскопического доступа; Systém na endoskopický prístup; Endoskopski sistem za dostop; Endoskopiskt åtkomstsystem; Endoskopik Erişim Sistemi; Система ендоскопічного доступу; 内窥镜接入系统

    Oct 11, 2024

    Product Code 10811955020701; OVT-027-160

    Part Number GRF-00081-00R11

  • OverTube™ Endoscopic Access System

    Instructions for Use

    Endoscopic Access System; Система за ендоскопски достъп; Systém pro endoskopický přístup; Endoskopisk adgangssystem; Endoskopisches Zugangssystem; Σύστημα ενδοσκοπικής πρόσβασης; Sistema de acceso endoscópico; Endpskoopiline ligipääsu süsteem; Endoskooppinen sisäänvientijärjestelmä; Système d'accès endoscopique; sustav za endoskopski pristup; Endoszkópos hozzáférési rendszer; Sistem Akses Endoskopi; Holspeglunaraðgangskerfi; Sistema di accesso endoscopico; 内視鏡アクセスシステム; 내시경 접근 시스템; Endoskopinės prieigos sistema; Endoskopiskā piekļuves sistēma; Endoskopisk tilgangssystem; Endoscopisch toegangssysteem; System dostępu endoskopowego; Sistema de acesso endoscópico; Sistema de acesso endoscópico; Sistem de acces endoscopic; Система для эндоскопического доступа; Systém na endoskopický prístup; Endoskopski sistem za dostop; Endoskopiskt åtkomstsystem; Endoskopik Erişim Sistemi; Система ендоскопічного доступу; 内窥镜接入系统

    Oct 11, 2024

    Product Code 10811955020701; OVT-027-160

    Part Number GRF-00081-00R09

  • OverTube™ Endoscopic Access System

    Instructions for Use

    Endoscopic Access System; Система за ендоскопски достъп; Systém pro endoskopický přístup; Endoskopisk adgangssystem; Endoskopisches Zugangssystem; Σύστημα ενδοσκοπικής πρόσβασης; Sistema de acceso endoscópico; Endpskoopiline ligipääsu süsteem; Endoskooppinen sisäänvientijärjestelmä; Système d'accès endoscopique; sustav za endoskopski pristup; Endoszkópos hozzáférési rendszer; Sistem Akses Endoskopi; Holspeglunaraðgangskerfi; Sistema di accesso endoscopico; 内視鏡アクセスシステム; 내시경 접근 시스템; Endoskopinės prieigos sistema; Endoskopiskā piekļuves sistēma; Endoskopisk tilgangssystem; Endoscopisch toegangssysteem; System dostępu endoskopowego; Sistema de acesso endoscópico; Sistema de acesso endoscópico; Sistem de acces endoscopic; Система для эндоскопического доступа; Systém na endoskopický prístup; Endoskopski sistem za dostop; Endoskopiskt åtkomstsystem; Endoskopik Erişim Sistemi; Система ендоскопічного доступу; 内窥镜接入系统

    Oct 11, 2024

    Product Code 10811955020701; OVT-027-160

    Part Number GRF-00081-00R08

  • OverTube™ Endoscopic Access System

    Instructions for Use

    Endoscopic Access System; Система за ендоскопски достъп; Systém pro endoskopický přístup; Endoskopisk adgangssystem; Endoskopisches Zugangssystem; Σύστημα ενδοσκοπικής πρόσβασης; Sistema de acceso endoscópico; Endpskoopiline ligipääsu süsteem; Endoskooppinen sisäänvientijärjestelmä; Système d'accès endoscopique; sustav za endoskopski pristup; Endoszkópos hozzáférési rendszer; Sistem Akses Endoskopi; Holspeglunaraðgangskerfi; Sistema di accesso endoscopico; 内視鏡アクセスシステム; 내시경 접근 시스템; Endoskopinės prieigos sistema; Endoskopiskā piekļuves sistēma; Endoskopisk tilgangssystem; Endoscopisch toegangssysteem; System dostępu endoskopowego; Sistema de acesso endoscópico; Sistema de acesso endoscópico; Sistem de acces endoscopic; Система для эндоскопического доступа; Systém na endoskopický prístup; Endoskopski sistem za dostop; Endoskopiskt åtkomstsystem; Endoskopik Erişim Sistemi; Система ендоскопічного доступу; 内窥镜接入系统

    Oct 11, 2024

    Product Code 10811955020701; OVT-027-160

    Part Number GRF-00081-00R07

Customer Support

If you have difficulties accessing documents, or would like to request a paper copy of literature from this site, contact Customer Service or your local Country Contact.

Get Adobe Reader

For best results, use Adobe Reader to view Boston Scientific literature. Download the latest version at no charge.

Adobe® and Reader® are trademarks of Adobe Systems Incorporated.