Directions for Use and Product Manuals for Healthcare Professionals

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  • "Bionic Navigator™ 1.2 Software Guide"

    Jan 05, 2018

    PDF( 2.0 MB )

    Model(s): SC-1160

    Part Number: 91171765-02

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • ACCOLADE™, ACCOLADE™ MRI, PROPONENT™, PROPONENT™ MRI, ESSENTIO™, ESSENTIO™ MRI, ALTRUA™ 2, FORMIO™, FORMIO™ MRI, VITALIO™, VITALIO™ MRI, INGENIO™, INGENIO™ MRI, ADVANTIO™ - PHYSICIAN’S TECHNICAL MANUAL

    Mar 01, 2018

    PACEMAKER

    PDF( 960.0 KB )

    Model(s): L300, L301, L321, L310, L311, L331, L200, L201, L221, L210, L211, L231, L100, L101, L121, L110, L111, L131, S701, S702, S722, K278, K279, K272, K273, K274, K275, K276, K277, K172, K173, K174, K175, K176, K177, K062, K063, K064

    Part Number: 359248-002

    Field Action Number: Z-0354-2018, Z-0355-2018, Z-0356-2018, Z-0357-2018, Z-0358-2018, Z-0359-2018, Z-0360-2018, Z-0361-2018, Z-0362-2018, Z-0363-2018, Z-0364-2018, Z-0365-2018, Z-0366-2018, Z-0367-2018, Z-0368-2018, Z-0369-2018, Z-0370-2018, Z-0371-2018, Z-0372-2018, Z-0373-2018, Z-0374-2018, Z-0375-2018, Z-0376-2018, Z-0377-2019

    Safety Related Revision? Yes

    1. Electrophysiology
    1. Pacemakers
    1. Directions for Use

  • ACCOLADE™, ACCOLADE™ MRI, PROPONENT™, PROPONENT™ MRI, ESSENTIO™, ESSENTIO™ MRI, ALTRUA™ 2, FORMIO™, FORMIO™ MRI, VITALIO™, VITALIO™ MRI, INGENIO™, INGENIO™ MRI, ADVANTIO™ -REFERENCE GUIDE

    Apr 01, 2018

    PACEMAKER

    PDF( 5.0 MB )

    Model(s): L300, L301, L321, L310, L311, L331, L200, L201, L221, L210, L211, L231, L100, L101, L121, L110, L111, L131, S701, S702, S722, K278, K279, K272, K273, K274, K275, K276, K277, K172, K173, K174, K175, K176, K177, K062, K063, K064

    Part Number: 359239-002

    Field Action Number: Z-0354-2018, Z-0355-2018, Z-0356-2018, Z-0357-2018, Z-0358-2018, Z-0359-2018, Z-0360-2018, Z-0361-2018, Z-0362-2018, Z-0363-2018, Z-0364-2018, Z-0365-2018, Z-0366-2018, Z-0367-2018, Z-0368-2018, Z-0369-2018, Z-0370-2018, Z-0371-2018, Z-0372-2018, Z-0373-2018, Z-0374-2018, Z-0375-2018, Z-0376-2018, Z-0377-2019

    Safety Related Revision? Yes

    1. Electrophysiology
    1. Pacemakers
    1. Reference Guides

  • AccuStick™ Needle or Guidewires - Directions for Use

    Dec 01, 2010

    Introducer Needle or Guidewire for use with AccuStick™ II Introducer System

    PDF( 76.0 KB )

    Part Number: 90595486-01A

    Safety Related Revision? Not-Applicable

    1. Interventional Radiology
    1. Introducer Sheaths
    1. Directions for Use

  • ACUITY® Pro - Directions For Use

    Aug 01, 2014

    9F Guide Catheter

    PDF( 130.0 KB )

    Part Number: 90981810-01A

    Safety Related Revision? No

    1. Electrophysiology
    1. Accessories
    2. Catheters Guide
    1. Directions for Use

  • ACUITY® Pro - Directions For Use

    Aug 01, 2014

    7F Guide Catheter

    PDF( 61.0 KB )

    Part Number: 90981811-01A

    Safety Related Revision? No

    1. Electrophysiology
    1. Catheters Guide
    2. Accessories
    1. Directions for Use

  • ACUITY® Spiral - PHYSICIAN’S LEAD MANUAL

    Sep 01, 2013

    Implantable Lead

    PDF( 483.0 KB )

    Model(s): 4591, 4592, 4593

    Part Number: 357271-005

    Safety Related Revision? No

    1. Electrophysiology
    1. Leads
    1. Directions for Use

  • ACUITY™ Steerable - Physician's Lead Manual

    Jan 05, 2011

    Coronary Venous Steroid-Eluting Bipolar Electrode J-shaped Fixation Pace/Sense Lead

    PDF( 747.0 KB )

    Model(s): 4554, 4555

    Part Number: 357203-006

    1. Electrophysiology
    1. Leads
    1. Directions for Use

  • ACUITY™ X4 - PHYSICIAN’S LEAD MANUAL

    Dec 01, 2017

    Coronary Venous Pace/Sense Lead IS4 Four-Pole Connector

    PDF( 2.0 MB )

    Model(s): 4671, 4672, 4674, 4675, 4677, 4678

    Part Number: 359160-004

    Safety Related Revision? No

    1. Electrophysiology
    1. Leads
    1. Directions for Use

  • ALTRUA™ 20 and ALTRUA™ 40 - System Guide

    Jan 05, 2011

    Multiprogrammable Pacemakers

    PDF( 4.0 MB )

    Model(s): S201, S202, S203, S204, S205, S208, S401, S402, S403, S404

    Part Number: 357894-003

    1. Electrophysiology
    1. Pacemakers
    1. Reference Guides

  • ALTRUA™ 60 - System Guide

    Jan 05, 2011

    Multiprogrammable Pacemakers

    PDF( 4.0 MB )

    Model(s): S601, S602, S603, S605, S606

    Part Number: 357921-003

    1. Electrophysiology
    1. Pacemakers
    1. Reference Guides

  • AMS 700™ with MS Pump™ (OTL) Operating Room Manual

    Apr 01, 2018

    Penile Prosthesis

    PDF( 1.0 MB )

    Model(s): 72404282-10, 72404283-12, 72404284-14, 72404232-10, 72404233-12, 72404234-14, 72404302-10, 72404303-12, 72404252-10, 72404253-12

    Part Number: 92162622-01B

    Safety Related Revision? No

    1. Urology
    1. Penile Prosthesis
    1. Programming and Operator's Manuals

  • AMS 700™ with MS Pump™ - Instructions for Use

    Aug 01, 2017

    Penile Prosthesis Product Line

    PDF( 635.0 KB )

    Model(s): n/a

    Part Number: 92162915-01A

    Safety Related Revision? No

    1. Urology
    1. Penile Prosthesis
    1. Directions for Use

  • AMS 700™ with MS Pump™ Operating Room Manual

    Nov 01, 2017

    Penile Prosthesis

    PDF( 2.0 MB )

    Model(s): n/a

    Part Number: 92127382-01B

    Safety Related Revision? No

    1. Urology
    1. Penile Prosthesis
    1. Programming and Operator's Manuals

  • AMS 800™ - Operating Room Manual

    May 01, 2017

    Urinary Control System For Male Patients

    PDF( 4.0 MB )

    Part Number: 92116964-01A

    Safety Related Revision? No

    1. Urology
    1. Artificial Urinary Sphincter
    1. Programming and Operator's Manuals

  • AMS 800™ Instructions For Use

    Feb 01, 2017

    Urinary Control System For Male Patients

    PDF( 177.0 KB )

    Model(s): n/a

    Part Number: 1004681_A

    Safety Related Revision? No

    1. Urology
    1. Artificial Urinary Sphincter
    1. Directions for Use

  • AMS 800™ Instructions For Use

    May 01, 2017

    Urinary Control System For Male Patients

    PDF( 395.0 KB )

    Model(s): n/a

    Part Number: 92116951-01A

    Safety Related Revision? No

    1. Urology
    1. Artificial Urinary Sphincter
    1. Directions for Use

  • AMS Ambicor™ - Instructions for Use

    Aug 01, 2017

    Penile Prosthesis

    PDF( 297.0 KB )

    Model(s): n/a

    Part Number: 92113093-01A

    Safety Related Revision? No

    1. Urology
    1. Penile Prosthesis
    1. Directions for Use

  • AMS Ambicor™ Penile Prosthesis

    Jul 01, 2016

    Operating Room Manual

    PDF( 1.0 MB )

    Model(s): n/a

    Part Number: 22000018_J

    Safety Related Revision? No

    1. Urology
    1. Penile Prosthesis
    1. Programming and Operator's Manuals

  • AMS™ Disposable Dilators Instructions for Use

    Nov 01, 2016

    Instructions for Use

    PDF( 227.0 KB )

    Model(s): n/a

    Part Number: 230118-01_D

    Safety Related Revision? No

    1. Urology
    1. Accessories
    1. Directions for Use

  • AMS™ Quick Connect Instructions for Use

    Nov 01, 2016

    Sutureless Window Connectors

    PDF( 421.0 KB )

    Model(s): n/a

    Part Number: 230128-01_C

    Safety Related Revision? No

    1. Urology
    1. Accessories
    1. Directions for Use

  • 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 - PHYSICIAN’S TECHNICAL MANUAL

    Apr 01, 2017

    CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

    PDF( 595.0 KB )

    Model(s): G160, G161, G164, G166, G168, G150, G151, G154, G156, G158, G140, G141, G146, G148, G050, G051, G056, G058, N160, N161, N164, N140, N141, N050, N051, N118, N119

    Part Number: 359401-004

    1. Electrophysiology
    1. CRT-D
    1. Directions for Use

  • 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 GUIDE

    Apr 01, 2017

    CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

    PDF( 7.0 MB )

    Model(s): G160, G161, G164, G166, G168, G150, G151, G154, G156, G158, G140, G141, G146, G148, G050, G051, G056, G058, N160, N161, N164, N140, N141, N050, N051, N118, N119

    Part Number: 359405-003

    1. Electrophysiology
    1. CRT-D
    1. Reference Guides

  • AUTOGEN™ EL 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, TELIGEN™ 100 ICD - PHYSICIAN’S TECHNICAL MANUAL

    Apr 01, 2017

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    PDF( 583.0 KB )

    Model(s): D160, D161, D162, D163, D150, D151, D152, D153, D020, D021, D022, D023, D140, D141, D142, D143, D010, D011, D012, D013, D050, D051, D052, D053, D000, D001, D002, D003, E160, E161, E162, E163, E140, E141, E142, E143, E050, E051, E052, E053, E102, E110

    Part Number: 359403-004

    1. Electrophysiology
    1. Defibrillators
    2. Implantable Cardioverter Defibrillator (ICD)
    1. Directions for Use

  • AUTOGEN™ EL 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, TELIGEN™ 100 ICD - REFERENCE GUIDE

    Apr 01, 2017

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    PDF( 7.0 MB )

    Model(s): D160, D161, D162, D163, D150, D151, D152, D153, D020, D021, D022, D023, D140, D141, D142, D143, D010, D011, D012, D013, D050, D051, D052, D053, D000, D001, D002, D003, E160, E161, E162, E163, E140, E141, E142, E143, E050, E051, E052, E053, E102, E110

    Part Number: 359407-003

    1. Electrophysiology
    1. Defibrillators
    2. Implantable Cardioverter Defibrillator (ICD)
    1. Reference Guides

  • Avista™ MRI Percutaneous Lead

    Apr 11, 2016

    PDF( 655.0 KB )

    Model(s): SC-2408-xx

    Part Number: 91063583-01 Rev C

    Safety Related Revision? No

    1. Neurological Surgery
    2. Orthopaedic Surgery
    3. Pain Medicine
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Bionic Navigator™ 2.04 Installation Guide

    Sep 12, 2017

    PDF( 1.0 MB )

    Model(s): DB-7101-204, DB-7161, DB-7161-R, NM-7161, NM-7161-R

    Part Number: 92161116-01 REV A

    Safety Related Revision? No

    1. Neurological Surgery
    1. Deep Brain Stimulator Systems
    1. Directions for Use

  • Bionic Navigator™ 3D System Programming Manual

    Jan 12, 2018

    PDF( 3.0 MB )

    Model(s): NM-7153-11A, NM-7153-11AR, NM-7153-30, NM-7153-30R

    Part Number: 91170722-03

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Bionic Navigator™ 3D System Programming Manual

    Jan 12, 2018

    PDF( 3.0 MB )

    Model(s): NM-7153-11A, NM-7153-11AR, NM-7153-30, NM-7153-30R

    Part Number: 91170722-03

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Blazer Prime® HTD - Directions For Use

    Jan 01, 2015

    Temperature Ablation Catheters

    PDF( 156.0 KB )

    Part Number: 90927309-01A

    1. Electrophysiology
    1. Catheters Ablation
    1. Directions for Use

  • Blazer Prime® XP - Directions For Use

    Jan 01, 2015

    Temperature Ablation Catheter

    PDF( 211.0 KB )

    Part Number: 90927316-01A

    1. Electrophysiology
    1. Catheters Ablation
    1. Directions for Use

  • Blazer® II Blazer® II HTD - Directions For Use

    May 01, 2015

    Temperature Ablation Catheters

    PDF( 175.0 KB )

    Part Number: 90927318-01C

    1. Electrophysiology
    1. Catheters Ablation
    1. Directions for Use

  • Blazer® II XP - Directions For Use

    Jan 01, 2015

    Temperature Ablation Catheter

    PDF( 211.0 KB )

    Part Number: 90927317-01A

    1. Electrophysiology
    1. Catheters Ablation
    1. Directions for Use

  • Blazer™ Open-Irrigated - Directions for Use

    Jan 01, 2018

    Ablation Catheter

    PDF( 406.0 KB )

    Part Number: 50463687-01A

    Safety Related Revision? No

    1. Electrophysiology
    1. Catheters Ablation
    1. Directions for Use

  • BN 3D Programming Manual

    Jan 12, 2018

    PDF( 3.0 MB )

    Model(s): NM-7153-11A, NM-7153-11AR, NM-7153-30, NM-7153-30R, NM-7161, NM-7161-R, NM-7161-102, NM-7161-102-R

    Part Number: 91005932-05

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Boston Scientific DBS Reference Guide

    Aug 27, 2018

    PDF( 148.0 KB )

    Part Number: 92094272-07

    Safety Related Revision? No

    1. Neurological Surgery
    1. Deep Brain Stimulator Systems
    1. Reference Guides

  • Boston Scientific Spinal Cord Stimulator (SCS) Systems Reference Guide

    Jul 17, 2018

    PDF( 550.0 KB )

    Part Number: 91005942-07

    Safety Related Revision? No

    1. Neurological Surgery
    2. Orthopaedic Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use
    2. Reference Guides

  • CAPTIVATE SUMMARY - CLINICAL SUMMARY 

    Dec 01, 2016

    CAPTure Information Via Automatic Threshold Evaluation

    PDF( 389.0 KB )

    Part Number: 358487-025

    Safety Related Revision? No

    1. Electrophysiology
    1. Clinical Summaries

  • Carotid WALLSTENT™ MONORAIL™ ENDOPROSTHESIS - Directions For Use

    Nov 01, 2015

    Closed Cell Self-Expanding Stent

    PDF( 447.0 KB )

    Part Number: 91018684-01A

    Safety Related Revision? No

    1. Vascular Surgery
    1. Stents Vascular
    1. Directions for Use

  • Charger™ OVER-THE-WIRE - Directions for Use (for US-labeled product only)

    Aug 01, 2014

    PTA Balloon Dilatation Catheter

    PDF( 50.0 KB )

    Part Number: 90984769-01A

    Safety Related Revision? No

    1. Interventional Cardiology
    2. Vascular Surgery
    3. Interventional Radiology
    1. Catheters Balloon
    1. Directions for Use

  • Chilli II® - Directions For Use

    Jan 01, 2015

    Cooled Ablation Catheter

    PDF( 207.0 KB )

    Part Number: 90927230-01A

    1. Electrophysiology
    1. Catheters Ablation
    1. Directions for Use

  • Clik Anchor

    Dec 20, 2010

    PDF( 379.0 KB )

    Model(s): SC-4316

    Part Number: 9055951-001 Rev AB

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Clik X Anchor

    Sep 29, 2015

    PDF( 447.0 KB )

    Model(s): SC-4318

    Part Number: 91030578-01 REV C

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Clik™ X MRI Anchor

    Jul 27, 2015

    PDF( 764.0 KB )

    Model(s): SC-4319

    Part Number: 91030586-01 REV C

    Safety Related Revision? No

    1. Neurological Surgery
    2. Orthopaedic Surgery
    3. Pain Medicine
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Clinical Summary: Vercise™ DBS System for Parkinson's Disease

    Dec 11, 2017

    PDF( 757.0 KB )

    Part Number: 92127895-01 Rev C

    Safety Related Revision? No

    1. Neurological Surgery
    1. Deep Brain Stimulator Systems
    1. Clinical Summaries

  • Clinician Trial Manual

    Apr 16, 2018

    PDF( 344.0 KB )

    Model(s): SC-4108, SC-4116, SC-5132, SC-5160, SC-6360-32, SC-5160R

    Part Number: 91171767-01 Rev AB

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • COGENT-4 FIELD FOLLOWING STUDY - Clinical Summary

    Nov 23, 2011

    PDF( 195.0 KB )

    Part Number: 358487-012

    1. Electrophysiology
    1. CRT-D
    2. Pacemakers
    3. Implantable Cardioverter Defibrillator (ICD)
    1. Clinical Summaries

  • COGNATE STUDY - Clinical Summary

    May 02, 2012

    PDF( 111.0 KB )

    Part Number: 358487-016

    1. Electrophysiology
    1. CRT-P
    2. Pacemakers
    1. Clinical Summaries

  • COMPANION - Clinical Summary

    Nov 23, 2011

    PDF( 667.0 KB )

    Part Number: 358487-001

    1. Electrophysiology
    1. CRT-P
    2. CRT-D
    1. Clinical Summaries

  • Connecting to Nevro Leads

    Mar 01, 2017

    PDF( 213.0 KB )

    Part Number: 91131569-01

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Connecting Tube - Directions for Use

    Jan 01, 2011

    Used with Flexima™ Biliary Catheter System Kit, VTC™ Nephrostomy Catheter System Kit, Flexima™ APD™ Drainage Catheter System Kit, Flexima™ APDL Drainage Catheter System Kit, Flexima™ Nephrostomy Catheter System Kit

    PDF( 61.0 KB )

    Part Number: 90595536-01A

    Safety Related Revision? Not-Applicable

    1. Interventional Radiology
    1. Catheters Drainage
    1. Directions for Use

  • Constellation® - Directions For Use

    Apr 10, 2015

    Multiple Electrode Recording and Pacing Catheter

    PDF( 356.0 KB )

    Part Number: 90905078-01B

    Safety Related Revision? No

    1. Electrophysiology
    1. Catheters Diagnostic
    1. Directions for Use

  • CONTAK CD - Clinical Summary

    Nov 23, 2011

    PDF( 802.0 KB )

    Part Number: 358487-006

    1. Electrophysiology
    1. CRT-D
    1. Clinical Summaries

  • CONTAK RENEWAL - Clinical Summary

    Nov 23, 2011

    PDF( 112.0 KB )

    Part Number: 358487-007

    1. Electrophysiology
    1. CRT-D
    1. Clinical Summaries

  • CONTAK RENEWAL 3 AVT - Clinical Summary

    Nov 23, 2011

    PDF( 164.0 KB )

    Part Number: 358487-011

    1. Electrophysiology
    1. CRT-D
    2. CRT-P
    1. Clinical Summaries

  • CONTAK RENEWAL HOLTER STUDY - Clinical Summary

    May 02, 2012

    PDF( 87.0 KB )

    Part Number: 358487-017

    1. Electrophysiology
    1. CRT-P
    1. Clinical Summaries

  • CrossBoss™ - Directions For Use

    Aug 01, 2014

    Catheter

    PDF( 65.0 KB )

    Part Number: 90981783-01A

    Safety Related Revision? No

    1. Interventional Cardiology
    1. CTO Systems
    1. Directions for Use

  • CRT OPTIMIZATION ALGORITHM - Clinical Summary

    Nov 23, 2011

    PDF( 393.0 KB )

    Part Number: 358487-003

    1. Electrophysiology
    1. CRT-D
    2. CRT-P
    1. Clinical Summaries

  • CRT-D - Patient Handbook

    Mar 01, 2017

    Cardiac Resynchronization Therapy Defibrillator

    PDF( 3.0 MB )

    Part Number: 356965-008

    1. Electrophysiology
    1. CRT-D
    1. Patient Information

  • CRT-P - Patient Handbook

    Apr 01, 2014

    Cardiac Resynchronization Therapy

    PDF( 3.0 MB )

    Part Number: 356430-007

    Safety Related Revision? No

    1. Electrophysiology
    1. CRT-P
    1. Patient Information

  • CXR Rear Tip Extender (RTE) Kit Instructions for Use

    Jul 01, 2016

    Penile Prosthesis Product Line

    PDF( 97.0 KB )

    Model(s): n/a

    Part Number: 230129-01_C

    Safety Related Revision? No

    1. Urology
    1. Penile Prosthesis
    1. Directions for Use

  • CXR Rear Tip Extender (RTE) Kit Instructions for Use

    Jul 01, 2016

    Penile Prosthesis Product Line

    PDF( 78.0 KB )

    Model(s): n/a

    Part Number: 230132-01_C

    Safety Related Revision? No

    1. Urology
    1. Penile Prosthesis
    1. Directions for Use

  • DECREASE-HF - Clinical Summary

    Nov 23, 2011

    PDF( 183.0 KB )

    Part Number: 358487-002

    1. Electrophysiology
    1. CRT-D
    2. CRT-P
    1. Clinical Summaries

  • EASYTRAK® 2 - Physician's Lead Manual

    Jan 05, 2011

    Coronary Venous Steroid-Eluting Bipolar Pace/Sense Lead

    PDF( 2.0 MB )

    Model(s): 4517, 4518, 4520

    Part Number: 355898-004

    1. Electrophysiology
    1. Leads
    1. Directions for Use

  • EASYTRAK® 2 IS-1 - Physician's Lead Manual

    Jan 05, 2011

    Coronary Venous Steroid-Eluting Bipolar Pace/Sense Lead

    PDF( 885.0 KB )

    Model(s): 4542, 4543, 4544

    Part Number: 356994-003

    1. Electrophysiology
    1. Leads
    1. Directions for Use

  • EASYTRAK® 3 - Physician's Lead Manual

    Jan 05, 2011

    Coronary Venous Steroid-Eluting Bipolar Spiral Fixation Pace/Sense Lead

    PDF( 882.0 KB )

    Model(s): 4524, 4525, 4527

    Part Number: 356342-004

    1. Electrophysiology
    1. Leads
    1. Directions for Use

  • EASYTRAK® 3 IS-1 - Physician's Lead Manual

    Jan 05, 2011

    Coronary Venous Steroid-Eluting Bipolar Electrode Spiral Fixation Pace/Sense Lead

    PDF( 738.0 KB )

    Model(s): 4548, 4549, 4550

    Part Number: 356992-001

    1. Electrophysiology
    1. Leads
    1. Directions for Use

  • EASYTRAK®2+ IS-1 - PHYSICIAN'S LEAD MANUAL

    Nov 01, 2014

    Coronary Venous; Steroid-Eluting; Dual-Electrode; Pace/Sense Leads

    PDF( 13.0 MB )

    Model(s): 4542, 4543, 4544

    Part Number: 356994-007

    1. Electrophysiology
    1. Leads
    1. Directions for Use

  • EMBLEM™ S-ICD - Patient Handbook

    Aug 01, 2017

    PDF( 2.0 MB )

    Part Number: 359284-004

    Safety Related Revision? No

    1. Electrophysiology
    1. Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
    1. Patient Information

  • EMBLEM™ S-ICD - PROGRAMMER USER’S MANUAL

    Mar 01, 2017

    PDF( 2.0 MB )

    Model(s): 3200

    Part Number: 359464-002

    Safety Related Revision? No

    1. Electrophysiology
    1. Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
    1. Directions for Use

  • EMBLEM™ S-ICD - USER’S MANUAL

    Aug 01, 2017

    Subcutaneous Electrode

    PDF( 359.0 KB )

    Model(s): 3401

    Part Number: 359468-003

    Safety Related Revision? No

    1. Electrophysiology
    1. Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
    1. Directions for Use

  • EMBLEM™ S-ICD - USER’S MANUAL

    Aug 01, 2017

    Subcutaneous Electrode Insertion Tool

    PDF( 384.0 KB )

    Model(s): 4711

    Part Number: 359471-003

    Safety Related Revision? No

    1. Electrophysiology
    1. Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
    1. Directions for Use

  • EMBLEM™ S-ICD - USER’S MANUAL

    Aug 01, 2017

    Electrode Delivery System

    PDF( 757.0 KB )

    Model(s): 4712

    Part Number: 360244-001

    1. Electrophysiology
    1. Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
    1. Directions for Use

  • EMBLEM™ S-ICD - USER’S MANUAL

    Aug 01, 2017

    Subcutaneous Electrode

    PDF( 425.0 KB )

    Model(s): 3501

    Part Number: 360213-002

    Safety Related Revision? No

    1. Electrophysiology
    1. Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
    1. Directions for Use

  • EMBLEM™ S-ICD Automated Screening Tool (AST) - INSTRUCTIONS FOR USE

    Jun 01, 2016

    PDF( 5.0 MB )

    Model(s): 2889

    Part Number: 360195-001

    Safety Related Revision? No

    1. Electrophysiology
    1. Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
    1. Directions for Use

  • EMBLEM™ S-ICD, EMBLEM™ MRI S-ICD - USER’S MANUAL

    Sep 01, 2017

    SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    PDF( 1.0 MB )

    Model(s): A209, A219

    Part Number: 359480-003

    Safety Related Revision? No

    1. Electrophysiology
    1. Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
    1. Directions for Use

  • Emerge™ - Directions for Use

    Sep 01, 2014

    PTCA Dilatation Catheter

    PDF( 82.0 KB )

    Part Number: 90990229-01A

    Safety Related Revision? No

    1. Interventional Cardiology
    1. Catheters Balloon
    1. Directions for Use

  • ENABLE MRI - CLINICAL STUDY SUMMARY

    Sep 01, 2017

    PDF( 173.0 KB )

    Part Number: 92082300-001

    1. Electrophysiology
    1. CRT-D
    2. Defibrillators
    3. Leads
    4. Implantable Cardioverter Defibrillator (ICD)
    1. Clinical Summaries

  • ENDOTAK RELIANCE® - PHYSICIAN'S LEAD MANUAL

    Dec 01, 2012

    Steroid-Eluting; Extendable/Retractable; Helix Defibrillation Leads

    PDF( 533.0 KB )

    Model(s): 0157, 0158, 0137, 0138, 0180, 0181, 0182, 0183, 0184, 0185, 0186, 0187

    Part Number: 358987-001

    1. Electrophysiology
    1. Leads
    1. Directions for Use

  • ENDOTAK RELIANCE® G, ENDOTAK RELIANCE® SG - PHYSICIAN’S LEAD MANUAL

    May 01, 2013

    Steroid-Eluting, Tined Endocardial, Defibrillation Leads

    PDF( 512.0 KB )

    Model(s): 0174, 0175, 0176, 0177, 0170, 0171

    Part Number: 356093-007

    Safety Related Revision? No

    1. Electrophysiology
    1. Leads
    1. Directions for Use

  • ENDOTAK RELIANCE™ - PHYSICIAN’S LEAD MANUAL

    Mar 01, 2017

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

    PDF( 880.0 KB )

    Model(s): 0272, 0273, 0275, 0276, 0292, 0293, 0295, 0296

    Part Number: 358073-013

    1. Electrophysiology
    1. Leads
    1. Directions for Use

  • ENDOTAK RELIANCE™ - PHYSICIAN’S LEAD MANUAL

    Mar 01, 2017

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

    PDF( 826.0 KB )

    Model(s): 0262, 0263, 0265, 0266, 0282, 0283, 0285, 0286

    Part Number: 358077-007

    1. Electrophysiology
    1. Leads
    1. Directions for Use

  • ENTRY KIT - Directions for Use

    Sep 01, 2014

    For Use with Greenfield® Titanium Vena Cava Filter

    PDF( 42.0 KB )

    Part Number: 90979609-01A

    Safety Related Revision? No

    1. Interventional Radiology
    1. Embolic Protection
    1. Directions for Use

  • Epic™ - Understanding Iliac Artery Disease - Patient Information Guide

    May 01, 2015

    Vascular Self-Expanding Stent System

    PDF( 3.0 MB )

    Part Number: 90961048-02B

    Safety Related Revision? No

    1. Vascular Surgery
    1. Stents Vascular
    1. Patient Information

  • Epic™ Vascular - Directions For Use

    Sep 01, 2014

    Self-Expanding Stent System

    PDF( 224.0 KB )

    Part Number: 90984760-01A

    Safety Related Revision? No

    1. Interventional Cardiology
    2. Vascular Surgery
    3. Interventional Radiology
    1. Stents Vascular
    1. Directions for Use

  • Express® LD Iliac OVER-THE-WIRE and Express® LD Biliary OVER-THE-WIRE - Directions For Use

    Apr 01, 2015

    Premounted Stent System

    PDF( 207.0 KB )

    Part Number: 90991889-01A

    Safety Related Revision? Yes

    1. Interventional Cardiology
    2. Vascular Surgery
    3. Interventional Radiology
    1. Stents Vascular
    1. Directions for Use

  • Express® SD - Understanding Renal Artery Disease - Patient Information Guide

    Nov 01, 2015

    Premounted Stent System

    PDF( 3.0 MB )

    Part Number: 91075649-02A

    Safety Related Revision? No

    1. Peripheral Interventions
    1. Stents Vascular
    1. Patient Information

  • Express® SD Renal MONORAIL® and Express® SD Biliary MONORAIL® - Directions For Use

    Jun 01, 2016

    Premounted Stent System

    PDF( 173.0 KB )

    Part Number: 91153394-01A

    Safety Related Revision? No

    1. Peripheral Interventions
    1. Stents Vascular
    1. Directions for Use

  • Express™ LD - Patient Information Guide

    Sep 01, 2016

    Iliac Premounted Stent System

    PDF( 300.0 KB )

    Part Number: 50417990-02A

    Safety Related Revision? No

    1. Vascular Surgery
    1. Stents Vascular
    1. Patient Information

  • FilterWire EZ™ - Directions for Use

    Nov 01, 2017

    Embolic Protection System

    PDF( 797.0 KB )

    Part Number: 50606897-01A

    Safety Related Revision? No

    1. Interventional Cardiology
    2. Vascular Surgery
    1. Embolic Protection
    2. Stents Vascular
    1. Directions for Use

  • FilterWire EZ™ and Carotid WALLSTENT™ MONORAIL™ ENDOPROSTHESIS - Understanding Carotid Artery Stenting - Patient Information Guide

    Mar 01, 2016

    Embolic Protection System and Closed Cell Self-Expanding Stent

    PDF( 4.0 MB )

    Part Number: 91062830-02B

    Safety Related Revision? No

    1. Vascular Surgery
    1. Stents Vascular
    1. Patient Information

  • FINELINE™ II STEROX - PHYSICIAN’S LEAD MANUAL

    Dec 01, 2017

    Implantable Lead

    PDF( 638.0 KB )

    Model(s): 4456, 4457, 4458, 4459, 4479, 4480

    Part Number: 358975-005

    Safety Related Revision? No

    1. Electrophysiology
    1. Leads
    1. Directions for Use

  • FINELINE™ II STEROX EZ - PHYSICIAN’S LEAD MANUAL

    Dec 01, 2017

    Implantable Lead

    PDF( 643.0 KB )

    Model(s): 4469, 4470, 4471, 4472, 4473, 4474

    Part Number: 358976-005

    Safety Related Revision? No

    1. Electrophysiology
    1. Leads
    1. Directions for Use

  • FLEXTEND® - Physician's Lead Manual

    Jan 05, 2011

    Steroid-Eluting Extendable/Retractable Helix Pace/Sense Leads

    PDF( 520.0 KB )

    Model(s): 4086, 4087, 4088

    Part Number: 358047-001

    1. Electrophysiology
    1. Leads
    1. Directions for Use

  • Freelink™ Remote Control Directions for Use

    Sep 27, 2017

    PDF( 2.0 MB )

    Model(s): SC-5260, SC-5562-1

    Part Number: 91171771-02

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Freelink™ Remote Control Directions for Use (RC5250)

    May 01, 2017

    PDF( 2.0 MB )

    Model(s): SC-5250, SC-5552-1

    Part Number: 91005934-02 REV B

    Safety Related Revision? No

    1. Pain Medicine
    2. Neurological Surgery
    3. Orthopaedic Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • GDT1000 SENSING ACUTE STUDY - Clinical Summary

    Nov 23, 2011

    PDF( 116.0 KB )

    Part Number: 358487-005

    1. Electrophysiology
    1. CRT-D
    1. Clinical Summaries

  • Genesys HTA ProCerva™ - Directions For Use

    Oct 01, 2014

    Procedure Set

    PDF( 325.0 KB )

    Part Number: 90990402-01A

    Safety Related Revision? No

    1. Gynecology
    2. Surgical Gynecology
    1. Endometrial Ablation System
    1. Directions for Use

  • Gladiator™ - Directions for Use

    Oct 01, 2011

    PTA Balloon Dilatation Catheter

    PDF( 60.0 KB )

    Part Number: 90657937-01B

    Safety Related Revision? Not-Applicable

    1. Interventional Cardiology
    2. Vascular Surgery
    3. Interventional Radiology
    1. Catheters Balloon
    1. Directions for Use

  • Gladiator™ Elite OVER-THE-WIRE - Directions For Use

    Aug 01, 2014

    PTA Balloon Dilatation Catheter

    PDF( 51.0 KB )

    Part Number: 90984770-01A

    Safety Related Revision? No

    1. Interventional Cardiology
    2. Vascular Surgery
    3. Interventional Radiology
    1. Catheters Balloon
    1. Directions for Use

  • Guide to Replacement of Cardiac Implantable Pulse Generators

    May 14, 2014

    PDF( 2.0 MB )

    Part Number: 358331-002

    1. Electrophysiology
    1. CRT-P
    2. CRT-D
    3. Pacemakers
    4. Implantable Cardioverter Defibrillator (ICD)
    1. Miscellaneous

  • HEART CONNECT™ SYSTEM - INSTRUCTIONS FOR USE

    Aug 01, 2016

    For online meetings to share data from connected medical equipment Model 3933 (Heart Connect Local System), Model 3934 (Heart Connect Local Software), Model 3935 (iOS Remote Software), Model 3936 (Android Remote Software), Model 3937 (Desktop Remote Software)

    PDF( 368.0 KB )

    Model(s): 3933

    Part Number: 359494-002

    1. Electrophysiology
    1. Programmer
    1. Programming and Operator's Manuals
    2. Directions for Use

  • HeartLogic™ Heart Failure Diagnostic Service - PHYSICIAN’S TECHNICAL GUIDE

    May 01, 2017

    PDF( 392.0 KB )

    Model(s): 6290, 6299, D500, D501, D512, D513, D520, D521, D532, D533, G524, G525, G526, G528, G537, G547, G548, D120, D121, D220, D221, D232, D233, D400, D401, D412, D413, D420, D421, D432, D433, G124, G125, G126, G128, G138, G224, G225, G228, G237 G247, G248, G424, G425, G426, G428, G437, G447, G448

    Part Number: 360200-001

    1. Electrophysiology
    1. CRT-D
    2. Implantable Cardioverter Defibrillator (ICD)
    1. Directions for Use

  • ICD - Patient Handbook

    Mar 01, 2017

    Implantable Cardioverter Defibrillator Therapy

    PDF( 3.0 MB )

    Part Number: 356434-011

    1. Electrophysiology
    1. Defibrillators
    2. Implantable Cardioverter Defibrillator (ICD)
    1. Patient Information

  • ImageReady MRI Full Body Guidelines for Precision Montage MRI Spinal Cord Stimulator System

    Oct 01, 2016

    PDF( 628.0 KB )

    Model(s): SC-1200

    Part Number: 91035972-02 Rev A

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. MRI Information

  • ImageReady MRI Head Only Guidelines for Precision Spectra Spinal Cord Stimulator System

    Aug 01, 2015

    PDF( 697.0 KB )

    Model(s): SC-1132

    Part Number: 91057049-02 Rev A

    Safety Related Revision? No

    1. Pain Medicine
    2. Neurological Surgery
    3. Orthopaedic Surgery
    1. Spinal Cord Stimulator Systems
    1. MRI Information

  • ImageReadyTM MRI Guidelines for Boston Scientific Deep Brain Stimulation Systems

    Aug 27, 2018

    PDF( 307.0 KB )

    Model(s): DB-2201-30-DC DB-2201-45-DC DB-4600-C

    Part Number: 92195369-03

    Safety Related Revision? No

    1. Neurological Surgery
    1. Deep Brain Stimulator Systems
    1. Directions for Use

  • IMAGEREADY™ MR CONDITIONAL DEFIBRILLATION SYSTEM - MRI TECHNICAL GUIDE

    Apr 01, 2017

    PDF( 931.0 KB )

    Model(s): D000, D002, D010, D012, D020, D022, D050, D052, D140, D142, D150, D152, D160, D162, D232, D233, D412, D413, D432, D433, D512, D513, D532, D533, G058, G148, G158, G168, G237, G247, G437, G447, G537, G547, 0262, 0263, 0265, 0266, 0272, 0273, 0275, 0276, 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296, 4469, 4470, 4471, 4472, 4473, 4474, 4479, 4480, 4603, 4671, 4672, 4674, 4675, 4677, 4678, 6220, 6221, 6402, 7145, 7148, 7735, 7736, 7740, 7741, 7742

    Part Number: 359450-004

    1. Electrophysiology
    1. CRT-D
    2. Defibrillators
    3. Leads
    4. Implantable Cardioverter Defibrillator (ICD)
    1. MRI Information

  • IMAGEREADY™ MR CONDITIONAL DEFIBRILLATION SYSTEM - MRI TECHNICAL GUIDE

    Oct 01, 2017

    PDF( 3.0 MB )

    Model(s): D000, D002, D010, D012, D020, D022, D050, D052, D140, D142, D150, D152, D160, D162, D232, D233, D412, D413, D432, D433, D512, D513, D532, D533, G058, G148, G158, G168, G237, G247, 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: 359450-005

    1. Electrophysiology
    1. Imaging Systems
    1. MRI Information

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

    Feb 01, 2017

    PDF( 66.0 KB )

    Part Number: 92082295-001

    1. Electrophysiology
    1. CRT-D
    2. Defibrillators
    3. Leads
    4. Implantable Cardioverter Defibrillator (ICD)
    1. MRI Patient Guides

  • IMAGEREADY™ MR CONDITIONAL PACING SYSTEM - MRI TECHNICAL GUIDE

    Apr 01, 2018

    PDF( 2.0 MB )

    Model(s): K275, K277, 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

    Part Number: 360167-002

    Field Action Number: Z-0354-2018, Z-0355-2018, Z-0356-2018, Z-0357-2018, Z-0358-2018, Z-0359-2018, Z-0360-2018, Z-0361-2018, Z-0362-2018, Z-0363-2018, Z-0364-2018, Z-0365-2018, Z-0366-2018, Z-0367-2018, Z-0368-2018, Z-0369-2018, Z-0370-2018, Z-0371-2018, Z-0372-2018, Z-0373-2018, Z-0374-2018, Z-0375-2018, Z-0376-2018, Z-0377-2019

    Safety Related Revision? Yes

    1. Electrophysiology
    1. Pacemakers
    1. MRI Information

  • ImageReady™ MR Conditional S-ICD System - Patient Guide for MRI Scans

    Aug 01, 2015

    PDF( 61.0 KB )

    Part Number: 359477-001

    1. Electrophysiology
    1. Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
    1. MRI Patient Guides

  • IMAGEREADY™ MR CONDITIONAL S-ICD SYSTEM - MRI TECHNICAL GUIDE

    Nov 01, 2015

    Model A209 and A219 pulse generators and all models of Boston Scientific/Cameron Health subcutaneous electrodes

    PDF( 2.0 MB )

    Model(s): A209, A219

    Part Number: 359474-001

    1. Electrophysiology
    1. Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
    1. MRI Information

  • ImageReady™ MRI Head Only Guidelines for Spectra WaveWriter™ Spinal Cord Stimulator System

    May 01, 2017

    PDF( 304.0 KB )

    Model(s): SC-1160, SC-4401, SC-2158-30, SC-2158-50, SC-2218-30, SC-2218-50, SC-2352-50, SC-2366-50, SC-8216-50, SC-8336-50, SC-8352-50, SC-4316, SC-4318, SC-4320

    Part Number: 91171762-01 REV A

    Safety Related Revision? No

    1. Pain Medicine
    2. Neurological Surgery
    3. Orthopaedic Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Implantable Materials Kit

    Apr 19, 2010

    PDF( 35.0 KB )

    Model(s): SC-4600

    Part Number: 9055597-001 Rev B

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Indications for Use

    Sep 08, 2017

    PDF( 806.0 KB )

    Model(s): M365SC11320, M365SC1110020, M365SC11400, M365SC11600, M365SC1200

    Part Number: 91005946-02

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • INGEVITY™ - CLINICAL SUMMARY

    Mar 01, 2016

    PDF( 282.0 KB )

    Model(s): 7631, 7632, 7635, 7636, 7640, 7641, 7642, 7731, 7732, 7735, 7736, 7740, 7741, 7742

    Part Number: 358487-023

    1. Electrophysiology
    1. Leads
    1. Clinical Summaries

  • INGEVITY™ MRI - PHYSICIAN’S LEAD MANUAL

    Feb 01, 2018

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

    PDF( 1.0 MB )

    Model(s): 7735, 7736

    Part Number: 358658-008

    Safety Related Revision? No

    1. Electrophysiology
    1. Leads
    1. Directions for Use

  • INGEVITY™ MRI - PHYSICIAN’S LEAD MANUAL

    Feb 01, 2018

    Pace/Sense Lead, IS-1 Bipolar Connector, Tined Fixation

    PDF( 1.0 MB )

    Model(s): 7740, 7741, 7742

    Part Number: 358660-008

    Safety Related Revision? No

    1. Electrophysiology
    1. Leads
    1. Directions for Use

  • Innova™ - Understanding Peripheral Artery Disease - Patient Information Guide

    Jul 01, 2015

    Vascular Self-Expanding Stent System

    PDF( 2.0 MB )

    Part Number: 91062177-02A

    1. Vascular Surgery
    1. Stents Vascular
    1. Patient Information

  • Innova™ Vascular OVER-THE-WIRE - Directions For Use

    Jul 01, 2015

    Self-Expanding Stent System

    PDF( 305.0 KB )

    Part Number: 90958202-01B

    1. Vascular Surgery
    1. Stents Vascular
    1. Directions for Use

  • INSIGNIA I ULTRA STUDY - Clinical Summary

    May 02, 2012

    PDF( 90.0 KB )

    Part Number: 358487-014

    1. Electrophysiology
    1. CRT-P
    2. Pacemakers
    1. Clinical Summaries

  • INSIGNIA® I Ultra - System Guide

    Jan 06, 2011

    Multiprogrammable Pacemakers

    PDF( 3.0 MB )

    Model(s): 1190, 1290, 1291

    Part Number: 355668-006 Discontinued Product

    Discontinued Date: Oct 17, 2013

    1. Electrophysiology
    1. Pacemakers
    1. Reference Guides

  • IntellaNav MiFi™ XP - Directions for Use

    Apr 01, 2017

    Temperature Ablation Catheter

    PDF( 270.0 KB )

    Part Number: 90874002-01C

    Safety Related Revision? No

    1. Electrophysiology
    1. Catheters Ablation
    1. Directions for Use

  • IntellaNav™ MiFi Open-Irrigated

    Jan 01, 2017

    Ablation Catheter

    PDF( 405.0 KB )

    Part Number: 91165618-01A

    Safety Related Revision? No

    1. Electrophysiology
    1. Catheters Ablation
    1. Directions for Use

  • IntellaNav™ Open-Irrigated - Directions for Use

    Jan 01, 2018

    Ablation Catheter

    PDF( 429.0 KB )

    Part Number: 50463690-01A

    Safety Related Revision? No

    1. Electrophysiology
    1. Catheters Ablation
    1. Directions for Use

  • IntellaNav™ ST - Directions for Use

    Jan 01, 2018

    Ablation Catheter

    PDF( 277.0 KB )

    Part Number: 50476382-01B

    1. Electrophysiology
    1. Catheters Ablation
    1. Directions for Use

  • IntellaNav™ XP - Directions for Use

    Apr 01, 2017

    Temperature Ablation Catheter

    PDF( 269.0 KB )

    Part Number: 90902676-01C

    Safety Related Revision? No

    1. Electrophysiology
    1. Catheters Ablation
    1. Directions for Use

  • IntellaTip MiFi™ Open-Irrigated - Directions for Use

    Nov 01, 2016

    Ablation Catheter

    PDF( 435.0 KB )

    Part Number: 91110327-01A

    Safety Related Revision? No

    1. Electrophysiology
    1. Catheters Ablation
    1. Directions for Use

  • IntellaTip MiFi™ XP Directions For Use

    May 01, 2015

    Temperature Ablation Catheter

    PDF( 233.0 KB )

    Part Number: 90948431-01B

    1. Electrophysiology
    1. Catheters Ablation
    1. Directions for Use

  • ION™ - Angioplasty and Stent Education Guide

    Feb 01, 2011

    Paclitaxel-Eluting Platinum Chromium Coronary Stent System

    PDF( 5.0 MB )

    Part Number: 90627944-02B

    Safety Related Revision? Not-Applicable

    1. Interventional Cardiology
    1. Stents Coronary
    1. Patient Information

  • ION™ - Directions For Use

    Mar 01, 2015

    Paclitaxel-Eluting Platinum Chromium Coronary Stent System

    PDF( 790.0 KB )

    Part Number: 90987252-01A

    Safety Related Revision? No

    1. Interventional Cardiology
    1. Stents Coronary
    1. Directions for Use

  • ION™ - Patient Information Guide

    Apr 01, 2011

    Paclitaxel-Eluting Platinum Chromium Coronary Stent System

    PDF( 254.0 KB )

    Part Number: 90461990-02C

    Safety Related Revision? Not-Applicable

    1. Interventional Cardiology
    1. Stents Coronary
    1. Patient Information

  • IVORY STUDY - Clinical Summary

    Jul 24, 2013

    PDF( 97.0 KB )

    Part Number: 358487-019

    1. Electrophysiology
    1. CRT-P
    2. Pacemakers
    1. Clinical Summaries

  • Labeling Symbols

    Aug 29, 2015

    PDF( 180.0 KB )

    Part Number: 91006762-01 REV B

    Safety Related Revision? No

    1. Pain Medicine
    2. Neurological Surgery
    3. Orthopaedic Surgery
    1. Spinal Cord Stimulator Systems
    1. Miscellaneous

  • Labeling Symbols

    Oct 30, 2015

    PDF( 565.0 KB )

    Part Number: 91006762-01 REV C

    Safety Related Revision? No

    1. Neurological Surgery
    2. Orthopaedic Surgery
    3. Pain Medicine
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • LATITUDE Consult™ System - CLINICIAN USER MANUAL

    May 01, 2017

    PDF( 3.0 MB )

    Model(s): 6299

    Part Number: 359165-004

    Safety Related Revision? No

    1. Electrophysiology
    1. Remote Patient Monitoring
    1. Clinician Manuals

  • LATITUDE Link™ - INSTALLATION AND OPERATION GUIDE

    Nov 01, 2016

    LATITUDE Link™ DATA MANAGEMENT SYSTEM

    PDF( 1.0 MB )

    Model(s): 6215, 6216

    Part Number: 359484-010

    Safety Related Revision? No

    1. Electrophysiology
    1. Remote Patient Monitoring
    1. Directions for Use
    2. Programming and Operator's Manuals

  • LATITUDE LINK™- LATITUDE LINK IDCO AND HL7 SPECIFICATIONS

    Feb 01, 2016

    LATITUDE Link Data Management System

    PDF( 405.0 KB )

    Model(s): 6215, 6216

    Part Number: 359485-001

    Safety Related Revision? No

    1. Electrophysiology
    1. Remote Patient Monitoring
    1. Integration Guides

  • LATITUDE® - Clinician Manual

    Aug 14, 2014

    LATITUDE® Patient Management System

    PDF( 2.0 MB )

    Model(s): 6488

    Part Number: 357242-017

    1. Electrophysiology
    1. Remote Patient Monitoring
    1. Clinician Manuals

  • LATITUDE® - Integration 2.01 Guide

    Aug 14, 2014

    LATITUDE® Patient Management System

    PDF( 1.0 MB )

    Model(s): 6464, 6497

    Part Number: 358549-002

    1. Electrophysiology
    1. Remote Patient Monitoring
    1. Integration Guides

  • LATITUDE® - Update to Communicator Patient Manual and DVD Video

    Aug 06, 2014

    LATITUDE® Patient Management System

    PDF( 141.0 KB )

    Model(s): 6476

    Part Number: 359234-001

    1. Electrophysiology
    1. Remote Patient Monitoring
    1. Supplemental Updates
    2. Patient Information

  • LATITUDE® Communicator Important Information

    Nov 01, 2015

    PDF( 48.0 KB )

    Model(s): 6280, 6290

    Part Number: 358080-001

    Safety Related Revision? No

    1. Electrophysiology
    1. Remote Patient Monitoring
    1. Supplemental Updates

  • LATITUDE® Communicator Patient Manual Supplement

    Aug 01, 2012

    Analog-to-Wireless Converter

    PDF( 1.0 MB )

    Model(s): 6456

    Part Number: 358829-001

    1. Electrophysiology
    1. Remote Patient Monitoring
    1. Patient Information
    2. Supplemental Updates

  • LATITUDE® PACEART® - Integration 1.01 Guide

    Aug 14, 2014

    LATITUDE® Patient Management System

    PDF( 2.0 MB )

    Model(s): 6472, 6444

    Part Number: 358545-002

    1. Electrophysiology
    1. Remote Patient Monitoring
    1. Integration Guides

  • LATITUDE® Patient Management - EMR Integration Security Certificate Installation & Configuration

    Jan 05, 2011

    PDF( 278.0 KB )

    Part Number: 357735-003

    1. Electrophysiology
    1. Remote Patient Monitoring
    1. Integration Guides

  • LATITUDE® Patient Management - EMR Integration Technical Application Overview

    Jan 04, 2011

    PDF( 2.0 MB )

    Part Number: 357729-003

    1. Electrophysiology
    1. Remote Patient Monitoring
    1. Integration Guides

  • LATITUDE® Patient Management - EMR Integration Testing Scenarios

    Jan 05, 2011

    PDF( 288.0 KB )

    Part Number: 357742-003

    1. Electrophysiology
    1. Remote Patient Monitoring
    1. Integration Guides

  • LATITUDE® Patient Management System - Update to LATITUDE Clinician Manual

    Feb 01, 2015

    Browser Requirements

    PDF( 83.0 KB )

    Model(s): 6488

    Part Number: 359440-001

    1. Electrophysiology
    1. Remote Patient Monitoring
    1. Clinician Manuals
    2. Supplemental Updates

  • LATITUDE™ Communicator - PATIENT MANUAL

    Aug 01, 2016

    PDF( 6.0 MB )

    Model(s): 6280, 6290

    Part Number: 359371-002

    Safety Related Revision? No

    1. Electrophysiology
    1. Remote Patient Monitoring
    1. Patient Information

  • LATITUDE™ Communicator - Patient Manual Supplement

    Mar 01, 2014

    LATITUDE™ Patient Management System

    PDF( 5.0 MB )

    Model(s): 6293

    Part Number: 359337-001

    1. Electrophysiology
    1. Remote Patient Monitoring
    1. Patient Information
    2. Supplemental Updates

  • LATITUDE™ Communicator - Patient Manual Supplement

    Feb 01, 2015

    Hotspot Feature and Wireless Internet Adapter

    PDF( 354.0 KB )

    Model(s): 6280, 6290, 6454

    Part Number: 359427-001

    Safety Related Revision? No

    1. Electrophysiology
    1. Remote Patient Monitoring
    1. Supplemental Updates
    2. Patient Information

  • LATITUDE™ Communicator Patient Literature Supplement

    Nov 01, 2017

    Model 6359 USB Cellular Adapter

    PDF( 566.0 KB )

    Model(s): 6280, 6290, 6359

    Part Number: 92185415-001

    Safety Related Revision? No

    1. Electrophysiology
    1. Remote Patient Monitoring
    1. Patient Information
    2. Supplemental Updates

  • LATITUDE™ NXT - CLINICIAN MANUAL

    Jul 01, 2017

    LATITUDE NXT Patient Management System

    PDF( 1.0 MB )

    Model(s): 6460, 6280, 6290, 6498, 6476

    Part Number: 358826-009

    Safety Related Revision? No

    1. Electrophysiology
    1. Remote Patient Monitoring
    1. Clinician Manuals

  • LATITUDE™ NXT - LATITUDE INTEGRATION IDCO AND HL7 SPECIFICATIONS

    Aug 01, 2016

    LATITUDE NXT Patient Management System

    PDF( 437.0 KB )

    Model(s): 6624, 6455

    Part Number: 359483-012

    Safety Related Revision? No

    1. Electrophysiology
    1. Remote Patient Monitoring
    1. Clinician Manuals
    2. Integration Guides

  • LATITUDE™ PROGRAMMING SYSTEM - OPERATOR’S MANUAL

    Oct 01, 2017

    PDF( 2.0 MB )

    Model(s): 3300

    Part Number: 359487-002

    1. Electrophysiology
    1. Programmer
    1. Programming and Operator's Manuals

  • Lead Delivery System Accessory Kit, IS-1 - Instructions for Use

    Jan 05, 2011

    PDF( 100.0 KB )

    Model(s): 7611

    Part Number: EL2045594

    1. Electrophysiology
    1. Leads
    1. Directions for Use

  • Lead Delivery System Accessory Kit, LV-1 - Instructions for Use

    Jan 05, 2011

    PDF( 66.0 KB )

    Model(s): 7610

    Part Number: EL2045620

    1. Electrophysiology
    1. Leads
    1. Directions for Use

  • Liberté® - Product Safety Information

    Sep 18, 2009

    Bare-Metal Coronary Stent System

    PDF( 609.0 KB )

    Safety Related Revision? Yes

    1. Interventional Cardiology
    1. Stents Coronary
    1. Supplemental Updates
    2. Directions for Use

  • Limited Warranty

    May 01, 2017

    PDF( 190.0 KB )

    Part Number: 91006760-01 REV D

    Safety Related Revision? No

    1. Pain Medicine
    2. Neurological Surgery
    3. Orthopaedic Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • MADIT-CRT - Clinical Summary

    Nov 23, 2011

    PDF( 1.0 MB )

    Part Number: 358487-013

    1. Electrophysiology
    1. CRT-D
    1. Clinical Summaries

  • MADIT-II - Clinical Summary

    Nov 23, 2011

    PDF( 256.0 KB )

    Part Number: 358487-004

    1. Electrophysiology
    1. Implantable Cardioverter Defibrillator (ICD)
    1. Clinical Summaries

  • MODEL 3300 LATITUDE™ PROGRAMMING SYSTEM SUPPLEMENT FOR PULSE GENERATOR MANUALS*

    Aug 01, 2017

    *Physician’s Technical Manuals and Reference Guides

    PDF( 141.0 KB )

    Model(s): 3300, D000, D001, D002, D003, D010, D011, D012, D013, D020, D021, D022, D023, D030, D031, D032, D033, D044, D045, D046, D047, D050, D051, D052, D053, D140, D141, D142, D143, D150, D151, D152, D153, D160, D161, D162, D163, D174, D175, D176, D177, E050, E051, E052, E053, E102, E103, E110, E111, E140, E141, E142, E143, E160, E161, E162, E163, F050, F051, F052, F053, F102, F103, F110, F111, F140, F141, F142, F143, F160, F161, F162, F163, G050, G051, G056, G058, G140, G141, G146, G148, G150, G151, G154, G156, G158, G160, G161, G164, G166, G168, G172, G173, G175, G177, G179, J062, J063, J064, J065, J066, J067, J172, J173, J174, J175, J176, J177, J178, J272, J273, J274, J275, J276, J277, J278, J279, K062, K063, K064, K065, K066, K067, K082, K083, K084, K085, K086, K087, K172, K173, K174, K175, K176, K177, K182, K183, K184, K185, K186, K187, K188, K272, K273, K274, K275, K276, K277, K278, K279, K282, K283, K284, K285, K286, K287, K288, K289, L058, L059, L100, L101, L110, L111, L121, L131, L200, L201, L209, L210, L211, L221, L231, L300, L301, L310, L311, L321, L331, N050, N051, N052, N053, N106, N107, N108, N118, N119, N140, N141, N142, N143, N160, N161, N162, N163, N164, N165, P052, P053, P106, P107, P108, P142, P143, P162, P163, P165, S701, S702, S722, U125, U128, U225, U226, U228, V172, V173, V182, V183, V272, V273, V274, V275, V282, V283, V284, V285, W172, W173, W272, W273, W274, W275

    Part Number: 92059496-020

    1. Electrophysiology
    1. CRT-D
    2. CRT-P
    3. Implantable Cardioverter Defibrillator (ICD)
    4. Programmer
    5. Pacemakers
    1. Supplemental Updates
    2. Directions for Use

  • MultiSENSE STUDY - HeartLogic™ Algorithm Development and Validation

    Oct 01, 2017

    PDF( 318.0 KB )

    Model(s): 6290, 6299, D500, D501, D512, D513, D520, D521, D532, D533, G524, G525, G526, G528, G537, G547, G548, D120, D121, D220, D221, D232, D233, D400, D401, D412, D413, D420, D421, D432, D433, G124, G125, G126, G128, G138, G224, G225, G228, G237 G247, G248, G424, G425, G426, G428, G437, G447, G448

    Part Number: 92029732-002

    Safety Related Revision? No

    1. Electrophysiology
    1. CRT-D
    2. Implantable Cardioverter Defibrillator (ICD)
    1. Clinical Summaries

  • NAVIGATE X4 - CLINICAL SUMMARY

    Jan 01, 2016

    NAVIGATE X4 STUDY with the ACUITY™ X4 lead family

    PDF( 1.0 MB )

    Model(s): 4671, 4672, 4674, 4675, 4677, 4678

    Part Number: 358487-022

    1. Electrophysiology
    1. Leads
    1. Clinical Summaries

  • NAVIGATE X4 STUDY - CLINICAL SUMMARY

    Sep 01, 2017

    NAVIGATE X4 STUDY with the RELIANCE 4-FRONT™ lead family

    PDF( 2.0 MB )

    Model(s): 0662, 0682, 0692, 0652, 0657, 0653, 0663, 0665, 0685, 0636, 0695, 0650 0672, 0654, 0675, 0686, 0696, 0673, 0693, 0658, 0676, 0683, 0651, 0655

    Part Number: 92156785-001

    1. Electrophysiology
    1. Leads
    1. Clinical Summaries

  • NC Emerge® - Directions For Use

    Jul 01, 2015

    PTCA Dilatation Catheter

    PDF( 77.0 KB )

    Part Number: 91074307-01A

    Safety Related Revision? No

    1. Interventional Cardiology
    1. Balloons Dilation and Extraction
    2. Catheters Balloon
    1. Directions for Use

  • Network and Connectivity - OPERATOR’S MANUAL

    Aug 01, 2017

    Application for use with the LATITUDE™ Programming System

    PDF( 743.0 KB )

    Model(s): 3300, 3924

    Part Number: 360165-002

    1. Electrophysiology
    1. Programmer
    1. Programming and Operator's Manuals

  • OMG™ Connector – A

    Apr 19, 2010

    PDF( 731.0 KB )

    Model(s): SC-9305

    Part Number: 9055568-002 Rev A

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • OMG™ Connector – M

    Apr 19, 2010

    PDF( 703.0 KB )

    Model(s): SC-9310

    Part Number: 9055562-002 Rev A

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • OptiCross™ - Directions For Use

    Sep 01, 2014

    40 MHz Coronary Imaging Catheter

    PDF( 209.0 KB )

    Part Number: 90986247-01A

    Safety Related Revision? No

    1. Interventional Cardiology
    1. Imaging Systems
    1. Directions for Use

  • OptiCross™ 18 - Directions For Use

    Jun 01, 2016

    30 MHz Peripheral Imaging Catheter

    PDF( 228.0 KB )

    Part Number: 91080532-01B

    Safety Related Revision? Not-Applicable

    1. Interventional Cardiology
    1. Catheters Diagnostic
    1. Directions for Use

  • OptiCross™ 6 - Directions for Use

    Nov 01, 2015

    40 MHz Coronary Imaging Catheter

    PDF( 229.0 KB )

    Model(s): H7495181160

    Part Number: 91062654-01A

    1. Interventional Cardiology
    1. Catheters Diagnostic
    1. Directions for Use

  • OptiCross™ X - Directions For Use

    Feb 01, 2016

    40 MHz Coronary Imaging Catheter

    PDF( 221.0 KB )

    Model(s): H74939405010

    Part Number: 90948769-01B

    Safety Related Revision? Not-Applicable

    1. Interventional Cardiology
    1. Catheters Diagnostic
    1. Directions for Use

  • Pacemaker Therapy

    Aug 01, 2014

    PDF( 656.0 KB )

    Part Number: 356429-010

    1. Electrophysiology
    1. Pacemakers
    1. Patient Information

  • Pacing System Analyzer (PSA) - OPERATOR’S MANUAL

    Dec 01, 2017

    Application for use with the LATITUDE™ Programming System

    PDF( 1.0 MB )

    Model(s): 3300, 3922

    Part Number: 360163-003

    Safety Related Revision? No

    1. Electrophysiology
    1. Programmer
    1. Programming and Operator's Manuals

  • Patient Data Management - OPERATOR’S MANUAL

    Aug 01, 2017

    Application for use with the LATITUDE™ Programming System

    PDF( 524.0 KB )

    Model(s): 3300, 3931

    Part Number: 360193-002

    1. Electrophysiology
    1. Programmer
    1. Programming and Operator's Manuals

  • Percutaneous Leads Directions for Use

    May 01, 2017

    PDF( 4.0 MB )

    Model(s): SC-2016-xx, SC-2016-xxE, SC-2138-xx, SC-2158-xx, SC-2158-xxE, SC-2208-xx, SC-2218-xx, SC-2218-xxE, SC-2352-xx, SC-2352-xxE, SC-2366-xx, SC-2366-xxE, SC-3138-xx, SC-3304-xx, SC-3354-xx, SC-2316-xx, SC-2316-xxE, SC-3400-xx, SC-2317-xx, SC-2317-xxE

    Part Number: 91078744-04 REV C

    Safety Related Revision? No

    1. Pain Medicine
    2. Neurological Surgery
    3. Orthopaedic Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Percutaneous Leads Directions for Use

    Jan 04, 2018

    PDF( 5.0 MB )

    Model(s): SC-2016-xx, SC-2016-xxE, SC-2138-xx, SC-2158-xx, SC-2158-xxE, SC-2208-xx, SC-2218-xx, SC-2218-xxE, SC-2352-xx, SC-2352-xxE, SC-2366-xx, SC-2366-xxE, SC-3138-xx, SC-3304-xx, SC-3354-xx, SC-2316-xx, SC-2316-xxE, SC-3400-xx, SC-2317-xx, SC-2317-xxE

    Part Number: 91078744-07

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Precision Clinician Manual

    Jan 05, 2018

    PDF( 6.0 MB )

    Model(s): SC-1110, SC-1110-02

    Part Number: 91083273-05

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Precision Clinician Manual Entrada 2

    Sep 08, 2017

    PDF( 8.0 MB )

    Model(s): M365SC42200, M365SC4220450, M365SC4220600, M365SC422S450, M365SC422S600

    Part Number: 91083273-04

    Safety Related Revision? No

    1. Pain Medicine
    2. Neurological Surgery
    3. Orthopaedic Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Precision Introducer Kit

    Apr 19, 2010

    PDF( 375.0 KB )

    Model(s): SC-4365

    Part Number: 9055579-002 Rev B

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Precision M8 Adapter

    Aug 29, 2015

    PDF( 659.0 KB )

    Model(s): SC-9218-15 , SC-9218-55 , SC-9218-15E , SC-9218-55E

    Part Number: 90893429-09 REV A

    Safety Related Revision? No

    1. Pain Medicine
    2. Neurological Surgery
    3. Orthopaedic Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Precision Montage MRI 16 Contact Implantable Pulse Generator Directions for Use

    Sep 01, 2016

    PDF( 826.0 KB )

    Model(s): SC-1200

    Part Number: 91053657-02 REV A

    Safety Related Revision? No

    1. Pain Medicine
    2. Neurological Surgery
    3. Orthopaedic Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Precision Montage™ MRI Information for Prescribers

    Jan 04, 2018

    PDF( 454.0 KB )

    Model(s): SC-1200

    Part Number: 91053659-02

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Precision Novi IPG DFU

    Apr 03, 2017

    PDF( 536.0 KB )

    Model(s): SC-1140

    Part Number: 91005926-01 Rev D

    Safety Related Revision? No

    1. Orthopaedic Surgery
    2. Pain Medicine
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Precision Novi™ Information for Presribers

    Jan 01, 2018

    PDF( 969.0 KB )

    Model(s): SC-1140

    Part Number: 91005929-02

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Precision Spectra IPG

    Aug 29, 2015

    PDF( 895.0 KB )

    Model(s): SC-1132

    Part Number: 91057051-01 REV A

    Safety Related Revision? No

    1. Pain Medicine
    2. Neurological Surgery
    3. Orthopaedic Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Precision Spectra™ Information for Prescribers

    Jan 04, 2018

    PDF( 837.0 KB )

    Model(s): SC-1132

    Part Number: 91008787-03

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Precision Spectra™ OMG

    May 01, 2017

    PDF( 177.0 KB )

    Part Number: 91171773-01 REV A

    Safety Related Revision? No

    1. Neurological Surgery
    2. Orthopaedic Surgery
    3. Pain Medicine
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Precision Spectra™ System Programming Manual

    Mar 10, 2016

    PDF( 3.0 MB )

    Model(s): NM-7151-30, NM-7151-30R, NM-7153-30, NM-7153-30R

    Part Number: 90834018-18 Rev A

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Programming and Operator's Manuals

  • Precision™ S8 Adapter

    Mar 10, 2016

    PDF( 644.0 KB )

    Model(s): SC-9208-15, SC-9208-55, SC-9208-15E, SC-9208-55E

    Part Number: 90893896-09 Rev A

    Safety Related Revision? No

    1. Neurological Surgery
    2. Pain Medicine
    3. Orthopaedic Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Precision™ S8 Adapter Directions for Use

    Jul 17, 2018

    PDF( 637.0 KB )

    Model(s): SC-9208-15, SC9208-55, SC-9208-15E, SC-9208-55E

    Part Number: 9089396-10 A

    Safety Related Revision? No

    1. Neurological Surgery
    2. Orthopaedic Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Programming Wand

    Jan 20, 2016

    PDF( 225.0 KB )

    Model(s): NM-7190

    Part Number: 91008426-02 REV A

    Safety Related Revision? No

    1. Neurological Surgery
    2. Orthopaedic Surgery
    3. Pain Medicine
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • PROMUS Element™ Plus - Angioplasty and Stent Education Guide

    Dec 01, 2014

    Everolimus-Eluting Platinum Chromium Coronary Stent System

    PDF( 345.0 KB )

    Part Number: 91005737-02A

    1. Interventional Cardiology
    1. Stents Coronary
    1. Patient Information

  • PROMUS Element™ Plus - Directions For Use

    Sep 01, 2016

    Everolimus-Eluting Platinum Chromium Coronary Stent System

    PDF( 471.0 KB )

    Part Number: 50417771-01A

    1. Interventional Cardiology
    1. Stents Coronary
    1. Directions for Use

  • PROMUS Element™ Plus - Patient Information Guide

    Jun 01, 2012

    Everolimus-Eluting Platinum Chromium Coronary Stent System

    PDF( 222.0 KB )

    Part Number: 90779470-02A

    Safety Related Revision? Not-Applicable

    1. Interventional Cardiology
    1. Stents Coronary
    1. Patient Information

  • Promus PREMIER™ - Angioplasty and Stent Education Guide

    Dec 01, 2014

    Everolimus-Eluting Platinum Chromium Coronary Stent System

    PDF( 502.0 KB )

    Part Number: 91004325-01A

    1. Interventional Cardiology
    1. Stents Coronary
    1. Patient Information

  • Promus PREMIER™ - Directions for Use

    Sep 01, 2016

    Everolimus-Eluting Platinum Chromium Coronary Stent System

    PDF( 523.0 KB )

    Part Number: 50417770-01A

    1. Interventional Cardiology
    1. Stents Coronary
    1. Directions for Use

  • Promus PREMIER™ - Patient Information Guide

    Dec 01, 2014

    Everolimus-Eluting Platinum Chromium Coronary Stent System

    PDF( 125.0 KB )

    Part Number: 90996662-02A

    1. Interventional Cardiology
    1. Stents Coronary
    1. Patient Information

  • PROMUS® - Patient Information Guide

    May 18, 2011

    Everolimus-Eluting Coronary Stent System

    PDF( 399.0 KB )

    Part Number: EL2077745

    Safety Related Revision? Not-Applicable

    1. Interventional Cardiology
    1. Stents Coronary
    1. Patient Information

  • PROMUS™ - Instructions for Use

    May 19, 2011

    Everolimus-Eluting Coronary Stent System

    PDF( 531.0 KB )

    Part Number: EL2078399

    Safety Related Revision? Not-Applicable

    1. Interventional Cardiology
    1. Stents Coronary
    1. Directions for Use

  • PULSAR MAX STUDY - Clinical Summary

    May 02, 2012

    PDF( 99.0 KB )

    Part Number: 358487-015

    1. Electrophysiology
    1. CRT-P
    2. Pacemakers
    1. Clinical Summaries

  • RAPIDO® - Instructions for Use

    Jan 05, 2011

    6F Guiding Catheter

    PDF( 60.0 KB )

    Model(s): 7720, 7721

    Part Number: EL2045909

    1. Electrophysiology
    1. Catheters Guide
    1. Directions for Use

  • RAPIDO® Cut-Away® - Instructions for Use

    Jan 03, 2011

    Guiding Catheter System

    PDF( 236.0 KB )

    Part Number: EL2045915

    1. Electrophysiology
    1. Catheters Guide
    1. Directions for Use

  • REBEL® - Directions for Use

    Jun 01, 2018

    Platinum Chromium Coronary Stent System

    PDF( 135.0 KB )

    Part Number: 50673276-01A

    Safety Related Revision? No

    1. Interventional Cardiology
    1. Stents Coronary
    1. Directions for Use

  • REBEL™ - Angioplasty and Stent Education Guide

    Jul 01, 2014

    Platinum Chromium Coronary Stent System

    PDF( 845.0 KB )

    Part Number: 90910311-01A

    Safety Related Revision? Not-Applicable

    1. Interventional Cardiology
    1. Stents Coronary
    1. Patient Information

  • REBEL™ - Patient Information Guide

    Dec 01, 2014

    Platinum Chromium Coronary Stent System

    PDF( 116.0 KB )

    Part Number: 90991555-02A

    Safety Related Revision? No

    1. Interventional Cardiology
    1. Stents Coronary
    1. Patient Information

  • Reference Guide

    Jun 12, 2017

    PDF( 552.0 KB )

    Part Number: 91005942-06

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • RELIANCE 4–FRONT™ - PHYSICIAN’S LEAD MANUAL

    Sep 01, 2017

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

    PDF( 2.0 MB )

    Model(s): 0654, 0682, 0683, 0655, 0685, 0686, 0650, 0662, 0663, 0651, 0636, 0665

    Part Number: 350062-007

    1. Electrophysiology
    1. Leads
    1. Directions for Use

  • RELIANCE 4–FRONT™ - PHYSICIAN’S LEAD MANUAL

    Sep 01, 2017

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

    PDF( 2.0 MB )

    Model(s): 0657, 0692, 0693, 0658, 0695, 0696, 0652, 0672, 0673, 0653, 0675, 0676

    Part Number: 350064-007

    1. Electrophysiology
    1. Leads
    1. Directions for Use

  • Reprocessing Instructions for the AMS Tools

    Sep 01, 2017

    Non Sterile

    PDF( 422.0 KB )

    Model(s): n/a

    Part Number: 1017012-01-MHA

    Safety Related Revision? No

    1. Urology
    1. Accessories
    1. Directions for Use

  • RESONATE™ HF CRT-D, RESONATE™ CRT-D, RESONATE™ X4 CRT-D, VIGILANT™ CRT-D, VIGILANT™ X4 CRT-D, MOMENTUM™ CRT-D, MOMENTUM™ X4 CRT-D - PHYSICIAN’S TECHNICAL MANUAL

    Apr 01, 2017

    CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

    PDF( 538.0 KB )

    Model(s): G524, G525, G526, G528, G537, G547, G548, G424, G425, G426, G428, G437, G447, G448, G224, G225, G228, G237, G247, G248, G124, G125, G126, G128, G138

    Part Number: 360198-002

    1. Electrophysiology
    1. CRT-D
    1. Directions for Use

  • RESONATE™ HF CRT-D, RESONATE™ CRT-D, RESONATE™ X4 CRT-D, VIGILANT™ CRT-D, VIGILANT™ X4 CRT-D, MOMENTUM™ CRT-D, MOMENTUM™ X4 CRT-D - REFERENCE GUIDE

    Apr 01, 2017

    CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

    PDF( 7.0 MB )

    Model(s): G524, G525, G526, G528, G537, G547, G548, G424, G425, G426, G428, G437, G447, G448, G224, G225, G228, G237, G247, G248, G124, G125, G126, G128, G138

    Part Number: 360196-002

    1. Electrophysiology
    1. CRT-D
    1. Reference Guides

  • RESONATE™ HF ICD, RESONATE™ EL ICD, PERCIVA™ HF ICD, PERCIVA™ ICD, VIGILANT™ EL ICD, MOMENTUM™ EL ICD - PHYSICIAN’S TECHNICAL MANUAL

    Apr 01, 2017

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    PDF( 521.0 KB )

    Model(s): D520, D521, D532, D533, D420, D421, D432, D433, D500, D501, D512, D513, D400, D401, D412, D413, D220, D221, D232, D233, D120, D121

    Part Number: 360199-002

    1. Electrophysiology
    1. Defibrillators
    2. Implantable Cardioverter Defibrillator (ICD)
    1. Directions for Use

  • RESONATE™ HF ICD, RESONATE™ EL ICD, PERCIVA™ HF ICD, PERCIVA™ ICD, VIGILANT™ EL ICD, MOMENTUM™ EL ICD - REFERENCE GUIDE

    Apr 01, 2017

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    PDF( 7.0 MB )

    Model(s): D520, D521, D532, D533, D420, D421, D432, D433, D500, D501, D512, D513, D400, D401, D412, D413, D220, D221, D232, D233, D120, D121

    Part Number: 360197-002

    Safety Related Revision? No

    1. Electrophysiology
    1. Defibrillators
    2. Implantable Cardioverter Defibrillator (ICD)
    1. Reference Guides

  • Rotablator™ - Peripheral RotaLink™ Plus - Directions for Use

    Feb 01, 2016

    Rotational Atherectomy System - Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device

    PDF( 124.0 KB )

    Part Number: 91119961-01A

    Safety Related Revision? No

    1. Interventional Cardiology
    2. Vascular Surgery
    3. Interventional Radiology
    1. Plaque Modification
    1. Directions for Use

  • Rotablator™ - Peripheral RotaWire™ Guidewire and wireClip™ Torquer - Directions for Use

    Aug 01, 2014

    Rotational Atherectomy System - Guidewire and Guidewire Manipulation Device

    PDF( 120.0 KB )

    Part Number: 90981826-01A

    Safety Related Revision? No

    1. Interventional Cardiology
    2. Interventional Radiology
    3. Vascular Surgery
    1. Plaque Modification
    1. Directions for Use

  • SAMURAI - CLINICAL SUMMARY

    Mar 01, 2016

    PDF( 305.0 KB )

    Model(s): 7731, 7732, 7735, 7736, 7740, 7741, 7742, K275, K277

    Part Number: 358487-024

    1. Electrophysiology
    1. Pacemakers
    2. Leads
    1. Clinical Summaries

  • SAVION DLVR™ SAVION FLX™ - Directions for Use

    Jul 01, 2018

    Guidewire with ICE™ Hydrophilic Coating

    PDF( 46.0 KB )

    Model(s): 1006-02

    Part Number: 50726992-01A

    1. Vascular Surgery
    1. CTO Systems
    1. Directions for Use

  • Spectra WaveWriter™ Information for Prescribers

    Jan 04, 2018

    PDF( 838.0 KB )

    Model(s): SC-1160

    Part Number: 91171759-02

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Spectra WaveWriter™ System Implantable Pulse Generator Directions for Use

    Sep 27, 2017

    PDF( 901.0 KB )

    Model(s): NM-7151-30, NM-7151-30R, NM-7153-12, NM-7153-12R, NM-7153-30, NM-7153-30R, NM-7153-11A, NM-7153-11AR, NM-7161, NM-7161-R, NM-7161-102, NM-7161-102-R, SC-7150, SC-7150-4, SC-7150-4R

    Part Number: 91157700-03

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Stingray™ - Directions For Use

    Aug 01, 2014

    Catheter

    PDF( 67.0 KB )

    Part Number: 90981782-01A

    Safety Related Revision? No

    1. Interventional Cardiology
    1. CTO Systems
    1. Directions for Use

  • Stingray™ - Directions for Use

    Jul 01, 2017

    Guidewire with Hydrophilic Coating

    PDF( 131.0 KB )

    Part Number: 50526083-01A

    Safety Related Revision? No

    1. Interventional Cardiology
    1. CTO Systems
    1. Directions for Use

  • Stingray™ - Directions for Use

    Jul 01, 2017

    Extension Wire

    PDF( 47.0 KB )

    Part Number: 50526084-01A

    Safety Related Revision? No

    1. Interventional Cardiology
    1. CTO Systems
    1. Directions for Use

  • SUPPLEMENTAL PROGRAMMER SOFTWARE INFORMATION

    Apr 15, 2014

    Supplemental Programmer Software Information for COGNIS™ CRT-D, TELIGEN™ ICD, PUNCTUA™, ENERGEN™, INCEPTA™, DYNAGEN™, INOGEN™, ORIGEN™ ICDs and CRT-Ds

    PDF( 76.0 KB )

    Model(s): D000, D001, D002, D003, D010, D011, D012, D013, D020, D021, D022, D023, D050, D051, D052, D053, D140, D141, D142, D143, D150, D151, D152, D153, E050, E051, E052, E053, E102, E110, E140, E141, E142, E143, E160, E161, E162, E163, G050, G051, G056, G058, G140, G141, G146, G148, G150, G151, G154, G156, G158, N050, N051, N118, N119, N140, N141, N160, N161, N164

    Part Number: 350007-003

    1. Electrophysiology
    1. CRT-D
    2. Implantable Cardioverter Defibrillator (ICD)
    1. Supplemental Updates
    2. Programming and Operator's Manuals

  • SureTek™ Burr Hole Cover DFU

    Nov 17, 2017

    PDF( 641.0 KB )

    Model(s): DB-4600-C

    Part Number: 92093581-01 Rev C

    Safety Related Revision? No

    1. Neurological Surgery
    1. Deep Brain Stimulator Systems
    1. Directions for Use

  • Surgical Leads Directions for Use

    Jan 04, 2018

    PDF( 821.0 KB )

    Model(s): SC-3138-xx, SC-8120-xx, SC-8216-xx, SC-8416-xx, SC-8336-xx, SC-8352-xxSC-3138-xx, SC-8120-xx, SC-8216-xx, SC-8336-xx, SC-8352-xx

    Part Number: 91078747-08

    Safety Related Revision? No

    1. Pain Medicine
    2. Orthopaedic Surgery
    3. Neurological Surgery
    1. Spinal Cord Stimulator Systems
    1. Directions for Use

  • Symphion™ - Directions For Use

    Dec 01, 2017

    Tissue Removal System

    PDF( 1.0 MB )

    Part Number: 91061461-01B

    Safety Related Revision? No

    1. Gynecology
    2. Surgical Gynecology
    3. Urology
    1. Uterine Tissue Removal Systems
    1. Directions for Use

  • Symphion™ - Directions For Use

    Dec 01, 2017

    6.3 Endoscope

    PDF( 430.0 KB )

    Part Number: 91061524-01

    Safety Related Revision? No

    1. Urology
    2. Gynecology
    3. Surgical Gynecology
    1. Uterine Tissue Removal Systems
    1. Directions for Use

  • SYNERGY™ - Angioplasty and Stent Education Guide

    Sep 01, 2015

    Everolimus-Eluting Platinum Chromium Coronary Stent System

    PDF( 1.0 MB )

    Part Number: 91004260-01B

    Safety Related Revision? Not-Applicable

    1. Interventional Cardiology
    1. Stents Coronary
    1. Patient Information

  • SYNERGY™ - Directions For Use

    Sep 01, 2016

    Everolimus-Eluting Platinum Chromium Coronary Stent System

    PDF( 190.0 KB )

    Part Number: 50417779-01A

    Safety Related Revision? No

    1. Interventional Cardiology
    1. Stents Coronary
    1. Directions for Use

  • SYNERGY™ - Patient Information Guide

    Oct 01, 2015

    Everolimus-Eluting Platinum Chromium Coronary Stent System

    PDF( 119.0 KB )

    Part Number: 91100239-02A

    Safety Related Revision? No

    1. Interventional Cardiology
    1. Stents Coronary
    1. Patient Information

  • TAXUS® Express²™ - Patient Information Guide

    Jul 01, 2009

    Paclitaxel-Eluting Coronary Stent System

    PDF( 1.0 MB )

    Part Number: 90511524-02A

    Safety Related Revision? Not-Applicable

    1. Interventional Cardiology
    1. Stents Coronary
    1. Patient Information

  • TAXUS® Express²™ and TAXUS® Express²™ Atom™ - Directions for Use

    Jun 01, 2012

    Paclitaxel-Eluting Coronary Stent System

    PDF( 2.0 MB )

    Part Number: 90776901-01A

    Safety Related Revision? Not-Applicable

    1. Interventional Cardiology
    1. Stents Coronary
    1. Directions for Use

  • TAXUS® Express²™ and TAXUS® Liberté® - Angioplasty and Stent Education Guide

    Jul 01, 2012

    Paclitaxel-Eluting Coronary Stent System

    PDF( 5.0 MB )

    Part Number: 90783182-02A

    Safety Related Revision? Not-Applicable

    1. Interventional Cardiology
    1. Stents Coronary
    1. Patient Information

  • TAXUS® Liberté® - Patient Information Guide

    Oct 01, 2010

    Paclitaxel-Eluting Coronary Stent System

    PDF( 3.0 MB )

    Part Number: 90555408-02A

    Safety Related Revision? Not-Applicable

    1. Interventional Cardiology
    1. Stents Coronary
    1. Patient Information

  • TAXUS® Liberté®, TAXUS® Liberté® Atom™, and TAXUS® Liberté® Long - Directions for Use

    May 01, 2013

    Paclitaxel-Eluting Coronary Stent System

    PDF( 501.0 KB )

    Part Number: 90814812-01A

    Safety Related Revision? Not-Applicable

    1. Interventional Cardiology
    1. Stents Coronary
    1. Directions for Use

  • Threader™ - Directions for Use

    Jul 01, 2014

    Micro-Dilatation Catheter

    PDF( 117.0 KB )

    Part Number: 90939120-01B

    Safety Related Revision? Not-Applicable

    1. Interventional Cardiology
    1. Catheters Balloon
    1. Directions for Use

  • TruePath™ CTO Device - Directions for Use

    Jan 01, 2012

    CTO Device

    PDF( 210.0 KB )

    Part Number: 90741285-01A

    Safety Related Revision? Not-Applicable

    1. Interventional Cardiology
    2. Vascular Surgery
    3. Interventional Radiology
    1. CTO Systems
    1. Directions for Use

  • TruePath™ Extension Wire - Directions for Use

    Jan 01, 2012

    Extension Wire

    PDF( 53.0 KB )

    Part Number: 90732646-01A

    Safety Related Revision? Not-Applicable

    1. Interventional Cardiology
    2. Vascular Surgery
    3. Interventional Radiology
    1. CTO Systems
    1. Directions for Use

  • Ultra ICE™ Plus - Directions For Use

    May 01, 2016

    9 MHz IntraCardiac Echo Catheter

    PDF( 191.0 KB )

    Part Number: 91040401-01B

    1. Interventional Cardiology
    1. Catheters Diagnostic
    1. Directions for Use

  • Ultra ICE™ Plus - PI - Directions for Use

    May 01, 2018

    Peripheral Imaging Catheter

    PDF( 170.0 KB )

    Part Number: 50677333-01A

    1. Interventional Cardiology
    1. Catheters Diagnostic
    1. Directions for Use

  • USB Data Management Utility

    Jan 05, 2011

    ZOOM® LATITUDE® Programming System

    PDF( 4.0 MB )

    Model(s): 3120

    Part Number: 358471-001

    1. Electrophysiology
    1. CRT-D
    2. CRT-P
    3. Pacemakers
    1. Integration Guides

  • VENTAK AV II - Clinical Summary

    Nov 23, 2011

    PDF( 101.0 KB )

    Part Number: 358487-008

    1. Electrophysiology
    1. Implantable Cardioverter Defibrillator (ICD)
    1. Clinical Summaries

  • VENTAK PRIZM® and VENTAK PRIZM® HE and VENTAK PRIZM® 2 - System Guide

    Jan 05, 2011

    Implantable Cardioverter Defibrillator (ICD)

    PDF( 3.0 MB )

    Model(s): 1850, 1851, 1852, 1853, 1855, 1856, 1857, 1858, 1860, 1861

    Part Number: 355239-010 Discontinued Product

    Discontinued Date: Oct 22, 2013

    1. Electrophysiology
    1. Implantable Cardioverter Defibrillator (ICD)
    1. Reference Guides

  • Vercise™ DBS Charger Handbook

    Sep 07, 2017

    PDF( 1.0 MB )

    Part Number: 92093582-01

    Safety Related Revision? No

    1. Neurological Surgery
    1. Deep Brain Stimulator Systems
    1. Directions for Use

  • Vercise™ DBS Physician Manual

    Aug 27, 2018

    PDF( 3.0 MB )

    Model(s): DB-1110-C DB-2201-30-DC DB-2201-45-DC NM-3138-55 DB-5110-C DB-5212-C DB-5500-1 DB-64125-US DB-4100-A DB-4254

    Part Number: 92093580-02

    Safety Related Revision? No

    1. Neurological Surgery
    1. Deep Brain Stimulator Systems
    1. Directions for Use

  • Vercise™ DBS Programming Manual

    Nov 17, 2017

    PDF( 3.0 MB )

    Model(s): DB-7101-204, DB-7161

    Part Number: 92161115-01 Rev B

    Safety Related Revision? No

    1. Neurological Surgery
    1. Deep Brain Stimulator Systems
    1. Directions for Use

  • Vercise™ M8 Adapter DFU

    Jun 15, 2018

    PDF( 370.0 KB )

    Model(s): DB-9218-15, DB-9218-55

    Part Number: 92093578-01

    Safety Related Revision? No

    1. Neurological Surgery
    1. Deep Brain Stimulator Systems
    1. Directions for Use

  • Vercise™ Patient Manual

    Dec 11, 2017

    PDF( 2.0 MB )

    Part Number: 92093579-01

    Safety Related Revision? No

    1. Neurological Surgery
    1. Deep Brain Stimulator Systems
    1. Directions for Use

  • VeriFLEX™ (Liberté®) - Directions for Use

    May 01, 2010

    Bare-Metal Coronary Stent System

    PDF( 253.0 KB )

    Part Number: 90590772-01A

    Safety Related Revision? Not-Applicable

    1. Interventional Cardiology
    1. Stents Coronary
    1. Directions for Use

  • VeriFLEX™ - Patient Information Guide

    Sep 01, 2009

    Bare-Metal Coronary Stent System

    PDF( 2.0 MB )

    Part Number: 90511593-01B

    Safety Related Revision? Not-Applicable

    1. Interventional Cardiology
    1. Stents Coronary
    1. Patient Information

  • VISIONIST™, VISIONIST™ X4, VALITUDE™, VALITUDE™ X4, INTUA™, INVIVE™ - PHYSICIAN’S TECHNICAL MANUAL

    Mar 01, 2018

    CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

    PDF( 1.0 MB )

    Model(s): U225, U226, U228, U125, U128, V272, V273, V172, V173

    Part Number: 359252-003

    Field Action Number: Z-0354-2018, Z-0355-2018, Z-0356-2018, Z-0357-2018, Z-0358-2018, Z-0359-2018, Z-0360-2018, Z-0361-2018, Z-0362-2018, Z-0363-2018, Z-0364-2018, Z-0365-2018, Z-0366-2018, Z-0367-2018, Z-0368-2018, Z-0369-2018, Z-0370-2018, Z-0371-2018, Z-0372-2018, Z-0373-2018, Z-0374-2018, Z-0375-2018, Z-0376-2018, Z-0377-2019

    Safety Related Revision? Yes

    1. Electrophysiology
    1. CRT-P
    1. Directions for Use

  • VISIONIST™, VISIONIST™ X4, VALITUDE™, VALITUDE™ X4, INTUA™, INVIVE™ - REFERENCE GUIDE

    Apr 01, 2018

    CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

    PDF( 7.0 MB )

    Model(s): U225, U226, U228, U125, U128, V272, V273, V172, V173

    Part Number: 359242-003

    Field Action Number: Z-0354-2018, Z-0355-2018, Z-0356-2018, Z-0357-2018, Z-0358-2018, Z-0359-2018, Z-0360-2018, Z-0361-2018, Z-0362-2018, Z-0363-2018, Z-0364-2018, Z-0365-2018, Z-0366-2018, Z-0367-2018, Z-0368-2018, Z-0369-2018, Z-0370-2018, Z-0371-2018, Z-0372-2018, Z-0373-2018, Z-0374-2018, Z-0375-2018, Z-0376-2018, Z-0377-2019

    Safety Related Revision? Yes

    1. Electrophysiology
    1. CRT-P
    1. Reference Guides

  • VITALITY - Clinical Summary

    Nov 23, 2011

    PDF( 99.0 KB )

    Part Number: 358487-009

    1. Electrophysiology
    1. CRT-D
    2. Implantable Cardioverter Defibrillator (ICD)
    1. Clinical Summaries

  • VITALITY DS - Clinical Summary

    Nov 23, 2011

    PDF( 91.0 KB )

    Part Number: 358487-010

    1. Electrophysiology
    1. Implantable Cardioverter Defibrillator (ICD)
    1. Clinical Summaries

  • VITALITY® 2 - System Guide

    Jan 05, 2011

    Implantable Cardioverter Defibrillator (ICD)

    PDF( 2.0 MB )

    Model(s): T165, T167, T175, T177

    Part Number: 357001-004

    1. Electrophysiology
    1. Implantable Cardioverter Defibrillator (ICD)
    1. Reference Guides

  • WALLSTENT™ RP Endoprosthesis WALLSTENT™ Endoprosthesis VENOUS - Patient Information Guide (for US-labeled product only)

    Mar 01, 2017

    Self-Expanding Stent

    PDF( 1.0 MB )

    Part Number: 50444283-02A

    Safety Related Revision? Not-Applicable

    1. Vascular Surgery
    1. Stents Vascular
    1. Patient Information

  • WATCHMAN® - Directions For Use

    Aug 01, 2015

    Left Atrial Appendage Closure Device with Delivery System

    PDF( 444.0 KB )

    Part Number: 90746221-01C

    Field Action Number: 91033431-FA

    Safety Related Revision? Yes

    1. Interventional Cardiology
    1. Left Atrial Appendage Closure System
    1. Directions for Use

  • WATCHMAN® Access System - Directions For Use

    Aug 01, 2015

    Access Sheath with Dilator

    PDF( 48.0 KB )

    Part Number: 91047128-01B

    Field Action Number: 91033431-FA

    Safety Related Revision? Yes

    1. Interventional Cardiology
    1. Left Atrial Appendage Closure System
    1. Directions for Use

  • WATCHMAN® Left Atrial Appendage Closure Device - Patient Information Guide

    Jun 21, 2015

    Left Atrial Appendage Closure Device

    PDF( 286.0 KB )

    Part Number: 91062999-02A

    Safety Related Revision? No

    1. Interventional Cardiology
    1. Left Atrial Appendage Closure System
    1. Patient Information

  • WATCHMAN™ TruSeal™ Access System - Directions for Use

    Jan 01, 2018

    Access Sheath with Dilator

    PDF( 47.0 KB )

    Part Number: 50533907-01A

    1. Interventional Cardiology
    1. Left Atrial Appendage Closure System
    1. Directions for Use

  • WHISPER VIEW™ - Instructions for Use

    Jan 05, 2011

    HI-TORQUE Guide Wire

    PDF( 2.0 MB )

    Model(s): 4634, 4635, 4636, 4637, 4638, 4639

    Part Number: 358067-002

    1. Electrophysiology
    1. Leads
    1. Directions for Use

  • Wolverine™ Coronary Cutting Balloon® - Directions for Use

    Feb 01, 2017

    Microsurgical Dilatation Device

    PDF( 86.0 KB )

    Part Number: 50482216-01A

    Safety Related Revision? Not-Applicable

    1. Interventional Cardiology
    1. Plaque Modification
    1. Directions for Use

  • Your ImageReady™ MR Conditional Pacing System and MRI Scans

    Jul 01, 2014

    PDF( 65.0 KB )

    Part Number: 359260-001

    1. Electrophysiology
    1. Pacemakers
    2. Leads
    1. MRI Patient Guides

  • ZOOM® LATITUDE® - OPERATOR’S MANUAL

    Apr 29, 2014

    Programmer/Recorder/Monitor

    PDF( 7.0 MB )

    Model(s): 3120

    Part Number: 357434-009

    1. Electrophysiology
    1. Remote Patient Monitoring
    1. Programming and Operator's Manuals

  • ZOOM® LATITUDE® - Operator’s Manual Supplement

    Mar 04, 2013

    Programmer/Recorder/Monitor

    PDF( 177.0 KB )

    Model(s): 3120

    Part Number: 359065-002

    1. Electrophysiology
    1. Remote Patient Monitoring
    1. Supplemental Updates
    2. Programming and Operator's Manuals