
Directions for Use and Product Manuals for Healthcare Professionals
These documents may change without notice; this website will always contain the most current version. Review manuals before using or implanting a device, or performing follow-up care.
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PLEASE NOTE:
- This website contains product literature for many, but not all, of Boston Scientific’s products.
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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
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- 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
Sep 01, 2014
PACEMAKER
PDF( 1.0 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: 359248-001
- Electrophysiology
- Pacemakers
- 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
Sep 01, 2014
PACEMAKER
PDF( 4.0 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: 359239-001
- Electrophysiology
- Pacemakers
- 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
- Interventional Radiology
- Introducer Sheaths
- 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
- Electrophysiology
- Accessories
- Catheters Guide
- 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
- Electrophysiology
- Catheters Guide
- Accessories
- 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
- Electrophysiology
- Leads
- 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
- Electrophysiology
- Leads
- Directions for Use
-
ACUITY™ X4 - PHYSICIAN’S LEAD MANUAL
Mar 01, 2017
Coronary Venous Pace/Sense Lead IS4 Four-Pole Connector
PDF( 820.0 KB )
Model(s): 4671, 4672, 4674, 4675, 4677, 4678
Part Number: 359160-003
- Electrophysiology
- Leads
- 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
- Electrophysiology
- Pacemakers
- 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
- Electrophysiology
- Pacemakers
- Reference Guides
-
AMS 700™ with MS Pump™ (OTL) Operating Room Manual
Aug 01, 2017
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: 92162622-01A
- Urology
- Penile Prosthesis
- Programming and Operator's Manuals
-
AMS 700™ with MS Pump™ Instructions for Use
Jul 01, 2016
Penile Prosthesis Product Line
PDF( 876.0 KB )
Model(s): n/a
Part Number: 230127-01_F
Safety Related Revision? No
- Urology
- Penile Prosthesis
- 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
- Urology
- Penile Prosthesis
- 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
- Urology
- Artificial Urinary Sphincter
- Directions for Use
-
AMS 800™ Operating Room Manual
Jul 01, 2016
Urinary Control System For Male Patients
PDF( 4.0 MB )
Model(s): n/a
Part Number: 1002487_A
Safety Related Revision? No
- Urology
- Artificial Urinary Sphincter
- Programming and Operator's Manuals
-
AMS Ambicor™ Instructions for Use
Nov 01, 2016
Penile Prosthesis
PDF( 476.0 KB )
Model(s): n/a
Part Number: 230119-01_E
Safety Related Revision? No
- Urology
- Penile Prosthesis
- 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
- Urology
- Penile Prosthesis
- 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
- Urology
- Accessories
- 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
- Urology
- Accessories
- 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
- Electrophysiology
- CRT-D
- 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
- Electrophysiology
- CRT-D
- 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
- Electrophysiology
- Defibrillators
- Implantable Cardioverter Defibrillator (ICD)
- 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
- Electrophysiology
- Defibrillators
- Implantable Cardioverter Defibrillator (ICD)
- 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
- Neurological Surgery
- Orthopaedic Surgery
- Pain Medicine
- Spinal Cord Stimulator Systems
- 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
- Neurological Surgery
- Deep Brain Stimulator Systems
- 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
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- 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
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- Directions for Use
-
Blazer Prime® HTD - Directions For Use
Jan 01, 2015
Temperature Ablation Catheters
PDF( 156.0 KB )
Part Number: 90927309-01A
- Electrophysiology
- Catheters Ablation
- Directions for Use
-
Blazer Prime® XP - Directions For Use
Jan 01, 2015
Temperature Ablation Catheter
PDF( 211.0 KB )
Part Number: 90927316-01A
- Electrophysiology
- Catheters Ablation
- 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
- Electrophysiology
- Catheters Ablation
- Directions for Use
-
Blazer® II XP - Directions For Use
Jan 01, 2015
Temperature Ablation Catheter
PDF( 211.0 KB )
Part Number: 90927317-01A
- Electrophysiology
- Catheters Ablation
- Directions for Use
-
Blazer® Open Irrigated - Directions for Use
Mar 01, 2016
Ablation Catheter
PDF( 345.0 KB )
Part Number: 90892169-01B
- Electrophysiology
- Catheters Ablation
- 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
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- Directions for Use
-
Boston Scientific DBS Reference Guide
Sep 12, 2017
PDF( 140.0 KB )
Part Number: 92094272-01 REV B
Safety Related Revision? No
- Neurological Surgery
- Deep Brain Stimulator Systems
- 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
- Electrophysiology
- 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
- Vascular Surgery
- Stents Vascular
- 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
- Interventional Cardiology
- Vascular Surgery
- Interventional Radiology
- Catheters Balloon
- Directions for Use
-
Chilli II® - Directions For Use
Jan 01, 2015
Cooled Ablation Catheter
PDF( 207.0 KB )
Part Number: 90927230-01A
- Electrophysiology
- Catheters Ablation
- 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
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- 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
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- 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
- Neurological Surgery
- Orthopaedic Surgery
- Pain Medicine
- Spinal Cord Stimulator Systems
- 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
- Neurological Surgery
- Deep Brain Stimulator Systems
- Clinical Summaries
-
Clinician Trial Manual
May 01, 2017
PDF( 321.0 KB )
Model(s): SC-4108, SC-4116, SC-5132, SC-5160, SC-6360-32
Part Number: 91171767-01 REV A
Safety Related Revision? No
- Neurological Surgery
- Orthopaedic Surgery
- Pain Medicine
- Spinal Cord Stimulator Systems
- Directions for Use
-
COGENT-4 FIELD FOLLOWING STUDY - Clinical Summary
Nov 23, 2011
PDF( 195.0 KB )
Part Number: 358487-012
- Electrophysiology
- CRT-D
- Pacemakers
- Implantable Cardioverter Defibrillator (ICD)
- Clinical Summaries
-
- Electrophysiology
- CRT-P
- Pacemakers
- Clinical Summaries
-
- Electrophysiology
- CRT-P
- CRT-D
- Clinical Summaries
-
Connecting to Nevro Leads
Mar 01, 2017
PDF( 213.0 KB )
Part Number: 91131569-01
Safety Related Revision? No
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- 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
- Interventional Radiology
- Catheters Drainage
- 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
- Electrophysiology
- Catheters Diagnostic
- Directions for Use
-
- Electrophysiology
- CRT-D
- Clinical Summaries
-
- Electrophysiology
- CRT-D
- Clinical Summaries
-
- Electrophysiology
- CRT-D
- CRT-P
- Clinical Summaries
-
- Electrophysiology
- CRT-P
- Clinical Summaries
-
CrossBoss™ - Directions For Use
Aug 01, 2014
Catheter
PDF( 65.0 KB )
Part Number: 90981783-01A
Safety Related Revision? No
- Interventional Cardiology
- CTO Systems
- Directions for Use
-
- Electrophysiology
- CRT-D
- CRT-P
- Clinical Summaries
-
CRT-D - Patient Handbook
Mar 01, 2017
Cardiac Resynchronization Therapy Defibrillator
PDF( 3.0 MB )
Part Number: 356965-008
- Electrophysiology
- CRT-D
- Patient Information
-
CRT-P - Patient Handbook
Apr 01, 2014
Cardiac Resynchronization Therapy
PDF( 3.0 MB )
Part Number: 356430-007
Safety Related Revision? No
- Electrophysiology
- CRT-P
- 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
- Urology
- Penile Prosthesis
- 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
- Urology
- Penile Prosthesis
- Directions for Use
-
- Electrophysiology
- CRT-D
- CRT-P
- 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
- Electrophysiology
- Leads
- 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
- Electrophysiology
- Leads
- 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
- Electrophysiology
- Leads
- 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
- Electrophysiology
- Leads
- 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
- Electrophysiology
- Leads
- Directions for Use
-
EMBLEM™ S-ICD - USER’S MANUAL
Sep 01, 2016
Subcutaneous Electrode
PDF( 256.0 KB )
Model(s): 3401
Part Number: 359468-002
Safety Related Revision? No
- Electrophysiology
- Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
- Directions for Use
-
EMBLEM™ S-ICD - USER’S MANUAL
Nov 01, 2016
Subcutaneous Electrode
PDF( 319.0 KB )
Model(s): 3501
Part Number: 360213-001
- Electrophysiology
- Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
- Directions for Use
-
EMBLEM™ S-ICD - USER’S MANUAL
Nov 01, 2016
Subcutaneous Electrode Insertion Tool
PDF( 237.0 KB )
Model(s): 4711
Part Number: 359471-002
Safety Related Revision? No
- Electrophysiology
- Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
- 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
- Electrophysiology
- Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
- Directions for Use
-
EMBLEM™ S-ICD Programmer - PROGRAMMER USER’S MANUAL
Nov 01, 2015
PDF( 2.0 MB )
Model(s): 3200
Part Number: 359464-001
Safety Related Revision? No
- Electrophysiology
- Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
- Programming and Operator's Manuals
-
EMBLEM™ S-ICD System - Patient Handbook
Oct 01, 2015
PDF( 2.0 MB )
Part Number: 359284-003
Safety Related Revision? No
- Electrophysiology
- Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
- Patient Information
-
EMBLEM™ S-ICD, EMBLEM™ MRI S-ICD - USER’S MANUAL
Nov 01, 2016
SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
PDF( 1.0 MB )
Model(s): A209, A219
Part Number: 359480-002
Safety Related Revision? No
- Electrophysiology
- Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
- 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
- Interventional Cardiology
- Catheters Balloon
- Directions for Use
-
- Electrophysiology
- CRT-D
- Defibrillators
- Leads
- Implantable Cardioverter Defibrillator (ICD)
- 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
- Electrophysiology
- Leads
- 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
- Electrophysiology
- Leads
- 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
- Electrophysiology
- Leads
- 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
- Electrophysiology
- Leads
- 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
- Interventional Radiology
- Embolic Protection
- 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
- Vascular Surgery
- Stents Vascular
- 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
- Interventional Cardiology
- Vascular Surgery
- Interventional Radiology
- Stents Vascular
- 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
- Interventional Cardiology
- Vascular Surgery
- Interventional Radiology
- Stents Vascular
- 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
- Peripheral Interventions
- Stents Vascular
- 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
- Peripheral Interventions
- Stents Vascular
- 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
- Vascular Surgery
- Stents Vascular
- Patient Information
-
FilterWire EZ™ - Directions For Use
Aug 01, 2014
Embolic Protection System
PDF( 665.0 KB )
Part Number: 90984750-01A
Safety Related Revision? No
- Interventional Cardiology
- Vascular Surgery
- Interventional Radiology
- Stents Vascular
- 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
- Vascular Surgery
- Stents Vascular
- Patient Information
-
FINELINE™ II Sterox - Physician's Lead Manual
May 01, 2014
Implantable Pacing Lead
PDF( 117.0 KB )
Model(s): 4456, 4457, 4458, 4459, 4479, 4480
Part Number: 355403-178
Safety Related Revision? No
- Electrophysiology
- Leads
- Directions for Use
-
FINELINE™ II STEROX - PHYSICIAN’S LEAD MANUAL
Mar 01, 2017
Implantable Lead
PDF( 547.0 KB )
Model(s): 4456, 4457, 4458, 4459, 4479, 4480
Part Number: 358975-004
- Electrophysiology
- Leads
- Directions for Use
-
FINELINE™ II Sterox EZ - Physician's Lead Manual
May 01, 2014
Implantable Pacing Lead
PDF( 143.0 KB )
Model(s): 4469, 4470, 4471, 4472, 4473, 4474
Part Number: 355405-241
Safety Related Revision? No
- Electrophysiology
- Leads
- Directions for Use
-
FINELINE™ II STEROX EZ - PHYSICIAN’S LEAD MANUAL
Mar 01, 2017
Implantable Lead
PDF( 659.0 KB )
Model(s): 4469, 4470, 4471, 4472, 4473, 4474
Part Number: 358976-004
- Electrophysiology
- Leads
- 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
- Electrophysiology
- Leads
- 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
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- 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
- Pain Medicine
- Neurological Surgery
- Orthopaedic Surgery
- Spinal Cord Stimulator Systems
- Directions for Use
-
- Electrophysiology
- CRT-D
- 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
- Gynecology
- Surgical Gynecology
- Endometrial Ablation System
- 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
- Interventional Cardiology
- Vascular Surgery
- Interventional Radiology
- Catheters Balloon
- 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
- Interventional Cardiology
- Vascular Surgery
- Interventional Radiology
- Catheters Balloon
- Directions for Use
-
Guide to Replacement of Cardiac Implantable Pulse Generators
May 14, 2014
PDF( 2.0 MB )
Part Number: 358331-002
- Electrophysiology
- CRT-P
- CRT-D
- Pacemakers
- Implantable Cardioverter Defibrillator (ICD)
- 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
- Electrophysiology
- Programmer
- Programming and Operator's Manuals
- 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
- Electrophysiology
- CRT-D
- Implantable Cardioverter Defibrillator (ICD)
- Directions for Use
-
ICD - Patient Handbook
Mar 01, 2017
Implantable Cardioverter Defibrillator Therapy
PDF( 3.0 MB )
Part Number: 356434-011
- Electrophysiology
- Defibrillators
- Implantable Cardioverter Defibrillator (ICD)
- 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
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- 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
- Pain Medicine
- Neurological Surgery
- Orthopaedic Surgery
- Spinal Cord Stimulator Systems
- MRI Information
-
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
- Electrophysiology
- CRT-D
- Defibrillators
- Leads
- Implantable Cardioverter Defibrillator (ICD)
- MRI Information
-
ImageReady™ MR Conditional Defibrillation System - Patient Guide for MRI Scans
Feb 01, 2017
PDF( 66.0 KB )
Part Number: 92082295-001
- Electrophysiology
- CRT-D
- Defibrillators
- Leads
- Implantable Cardioverter Defibrillator (ICD)
- MRI Patient Guides
-
IMAGEREADY™ MR CONDITIONAL PACING SYSTEM - MRI TECHNICAL GUIDE
Nov 01, 2016
PDF( 1.0 MB )
Model(s): K275, K277, 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: 360167-001
Safety Related Revision? No
- Electrophysiology
- Leads
- Pacemakers
- MRI Information
-
ImageReady™ MR Conditional S-ICD System - Patient Guide for MRI Scans
Aug 01, 2015
PDF( 61.0 KB )
Part Number: 359477-001
- Electrophysiology
- Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
- 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
- Electrophysiology
- Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
- 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
- Pain Medicine
- Neurological Surgery
- Orthopaedic Surgery
- Spinal Cord Stimulator Systems
- 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
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- 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
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- 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
- Electrophysiology
- Leads
- Clinical Summaries
-
INGEVITY™ MRI - PHYSICIAN’S LEAD MANUAL
Feb 01, 2017
Pace/Sense Lead IS-1 Bipolar Connector Extendable/Retractable Fixation
PDF( 497.0 KB )
Model(s): 7740, 7741, 7742
Part Number: 358658-007
- Electrophysiology
- Leads
- Directions for Use
-
INGEVITY™ MRI - PHYSICIAN’S LEAD MANUAL
Feb 01, 2017
Pace/Sense Lead IS-1 Bipolar Connector Tined Fixation
PDF( 477.0 KB )
Model(s): 7731, 7732, 7735, 7736
Part Number: 358660-007
- Electrophysiology
- Leads
- 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
- Vascular Surgery
- Stents Vascular
- 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
- Vascular Surgery
- Stents Vascular
- Directions for Use
-
- Electrophysiology
- CRT-P
- Pacemakers
- 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
- Electrophysiology
- Pacemakers
- 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
- Electrophysiology
- Catheters Ablation
- Directions for Use
-
IntellaNav™ Open-Irrigated - Directions for Use
May 01, 2017
Ablation Catheter
PDF( 371.0 KB )
Part Number: 91111934-01C
Safety Related Revision? No
- Electrophysiology
- Catheters Ablation
- Directions for Use
-
IntellaNav™ ST - Directions for Use
Jan 01, 2018
Ablation Catheter
PDF( 277.0 KB )
Part Number: 50476382-01B
- Electrophysiology
- Catheters Ablation
- 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
- Electrophysiology
- Catheters Ablation
- 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
- Electrophysiology
- Catheters Ablation
- Directions for Use
-
IntellaTip MiFi™ XP Directions For Use
May 01, 2015
Temperature Ablation Catheter
PDF( 233.0 KB )
Part Number: 90948431-01B
- Electrophysiology
- Catheters Ablation
- 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
- Interventional Cardiology
- Stents Coronary
- 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
- Interventional Cardiology
- Stents Coronary
- 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
- Interventional Cardiology
- Stents Coronary
- Patient Information
-
- Electrophysiology
- CRT-P
- Pacemakers
- Clinical Summaries
-
Labeling Symbols
Aug 29, 2015
PDF( 180.0 KB )
Part Number: 91006762-01 REV B
Safety Related Revision? No
- Pain Medicine
- Neurological Surgery
- Orthopaedic Surgery
- Spinal Cord Stimulator Systems
- Miscellaneous
-
Labeling Symbols
Oct 30, 2015
PDF( 565.0 KB )
Part Number: 91006762-01 REV C
Safety Related Revision? No
- Neurological Surgery
- Orthopaedic Surgery
- Pain Medicine
- Spinal Cord Stimulator Systems
- Directions for Use
-
LATITUDE Consult™ System - CLINICIAN USER MANUAL
Sep 01, 2016
PDF( 3.0 MB )
Model(s): 6299
Part Number: 359165-003
Safety Related Revision? No
- Electrophysiology
- Remote Patient Monitoring
- 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
- Electrophysiology
- Remote Patient Monitoring
- Directions for Use
- 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
- Electrophysiology
- Remote Patient Monitoring
- Integration Guides
-
LATITUDE® - Clinician Manual
Aug 14, 2014
LATITUDE® Patient Management System
PDF( 2.0 MB )
Model(s): 6488
Part Number: 357242-017
- Electrophysiology
- Remote Patient Monitoring
- 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
- Electrophysiology
- Remote Patient Monitoring
- 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
- Electrophysiology
- Remote Patient Monitoring
- Supplemental Updates
- 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
- Electrophysiology
- Remote Patient Monitoring
- 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
- Electrophysiology
- Remote Patient Monitoring
- Patient Information
- 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
- Electrophysiology
- Remote Patient Monitoring
- Integration Guides
-
LATITUDE® Patient Management - EMR Integration Security Certificate Installation & Configuration
Jan 05, 2011
PDF( 278.0 KB )
Part Number: 357735-003
- Electrophysiology
- Remote Patient Monitoring
- Integration Guides
-
LATITUDE® Patient Management - EMR Integration Technical Application Overview
Jan 04, 2011
PDF( 2.0 MB )
Part Number: 357729-003
- Electrophysiology
- Remote Patient Monitoring
- Integration Guides
-
LATITUDE® Patient Management - EMR Integration Testing Scenarios
Jan 05, 2011
PDF( 288.0 KB )
Part Number: 357742-003
- Electrophysiology
- Remote Patient Monitoring
- 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
- Electrophysiology
- Remote Patient Monitoring
- Clinician Manuals
- 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
- Electrophysiology
- Remote Patient Monitoring
- 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
- Electrophysiology
- Remote Patient Monitoring
- Patient Information
- 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
- Electrophysiology
- Remote Patient Monitoring
- Supplemental Updates
- 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
- Electrophysiology
- Remote Patient Monitoring
- Patient Information
- Supplemental Updates
-
LATITUDE™ NXT - CLINICIAN MANUAL
Sep 01, 2016
LATITUDE NXT Patient Management System
PDF( 1.0 MB )
Model(s): 6460, 6280, 6290, 6498, 6476
Part Number: 358826-008
Safety Related Revision? No
- Electrophysiology
- Remote Patient Monitoring
- 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
- Electrophysiology
- Remote Patient Monitoring
- Clinician Manuals
- Integration Guides
-
LATITUDE™ PROGRAMMING SYSTEM - OPERATOR’S MANUAL
Oct 01, 2017
PDF( 2.0 MB )
Model(s): 3300
Part Number: 359487-002
- Electrophysiology
- Programmer
- 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
- Electrophysiology
- Leads
- 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
- Electrophysiology
- Leads
- Directions for Use
-
Liberté® - Product Safety Information
Sep 18, 2009
Bare-Metal Coronary Stent System
PDF( 609.0 KB )
Safety Related Revision? Yes
- Interventional Cardiology
- Stents Coronary
- Supplemental Updates
- Directions for Use
-
Limited Warranty
May 01, 2017
PDF( 190.0 KB )
Part Number: 91006760-01 REV D
Safety Related Revision? No
- Pain Medicine
- Neurological Surgery
- Orthopaedic Surgery
- Spinal Cord Stimulator Systems
- Directions for Use
-
- Electrophysiology
- CRT-D
- Clinical Summaries
-
- Electrophysiology
- Implantable Cardioverter Defibrillator (ICD)
- 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
- Electrophysiology
- CRT-D
- CRT-P
- Implantable Cardioverter Defibrillator (ICD)
- Programmer
- Pacemakers
- Supplemental Updates
- 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
- Electrophysiology
- CRT-D
- Implantable Cardioverter Defibrillator (ICD)
- 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
- Electrophysiology
- Leads
- 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
- Interventional Cardiology
- Balloons Dilation and Extraction
- Catheters Balloon
- 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
- Electrophysiology
- Programmer
- 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
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- 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
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- 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
- Interventional Cardiology
- Imaging Systems
- 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
- Interventional Cardiology
- Catheters Diagnostic
- 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
- Interventional Cardiology
- Catheters Diagnostic
- 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
- Interventional Cardiology
- Catheters Diagnostic
- Directions for Use
-
- Electrophysiology
- Pacemakers
- Patient Information
-
Pacing System Analyzer (PSA) - OPERATOR’S MANUAL
Aug 01, 2017
Application for use with the LATITUDE™ Programming System
PDF( 1.0 MB )
Model(s): 3300, 3922
Part Number: 360163-002
- Electrophysiology
- Programmer
- 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
- Electrophysiology
- Programmer
- 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
- Pain Medicine
- Neurological Surgery
- Orthopaedic Surgery
- Spinal Cord Stimulator Systems
- 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
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- 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
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- 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
- Pain Medicine
- Neurological Surgery
- Orthopaedic Surgery
- Spinal Cord Stimulator Systems
- 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
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- 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
- Pain Medicine
- Neurological Surgery
- Orthopaedic Surgery
- Spinal Cord Stimulator Systems
- 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
- Pain Medicine
- Neurological Surgery
- Orthopaedic Surgery
- Spinal Cord Stimulator Systems
- 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
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- 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
- Orthopaedic Surgery
- Pain Medicine
- Neurological Surgery
- Spinal Cord Stimulator Systems
- 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
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- 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
- Pain Medicine
- Neurological Surgery
- Orthopaedic Surgery
- Spinal Cord Stimulator Systems
- 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
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- Directions for Use
-
Precision Spectra™ OMG
May 01, 2017
PDF( 177.0 KB )
Part Number: 91171773-01 REV A
Safety Related Revision? No
- Neurological Surgery
- Orthopaedic Surgery
- Pain Medicine
- Spinal Cord Stimulator Systems
- 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
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- 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
- Neurological Surgery
- Pain Medicine
- Orthopaedic Surgery
- Spinal Cord Stimulator Systems
- 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
- Neurological Surgery
- Orthopaedic Surgery
- Pain Medicine
- Spinal Cord Stimulator Systems
- 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
- Interventional Cardiology
- Stents Coronary
- 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
- Interventional Cardiology
- Stents Coronary
- 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
- Interventional Cardiology
- Stents Coronary
- 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
- Interventional Cardiology
- Stents Coronary
- 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
- Interventional Cardiology
- Stents Coronary
- 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
- Interventional Cardiology
- Stents Coronary
- 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
- Interventional Cardiology
- Stents Coronary
- 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
- Interventional Cardiology
- Stents Coronary
- Directions for Use
-
- Electrophysiology
- CRT-P
- Pacemakers
- Clinical Summaries
-
RAPIDO® - Instructions for Use
Jan 05, 2011
6F Guiding Catheter
PDF( 60.0 KB )
Model(s): 7720, 7721
Part Number: EL2045909
- Electrophysiology
- Catheters Guide
- Directions for Use
-
RAPIDO® Cut-Away® - Instructions for Use
Jan 03, 2011
Guiding Catheter System
PDF( 236.0 KB )
Part Number: EL2045915
- Electrophysiology
- Catheters Guide
- 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
- Interventional Cardiology
- Stents Coronary
- Patient Information
-
REBEL™ - Directions For Use
Sep 01, 2014
Platinum Chromium Coronary Stent System
PDF( 100.0 KB )
Part Number: 90991566-01A
Safety Related Revision? No
- Interventional Cardiology
- Stents Coronary
- Directions for Use
-
REBEL™ - Patient Information Guide
Dec 01, 2014
Platinum Chromium Coronary Stent System
PDF( 116.0 KB )
Part Number: 90991555-02A
Safety Related Revision? No
- Interventional Cardiology
- Stents Coronary
- Patient Information
-
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- 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
- Urology
- Accessories
- 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
- Electrophysiology
- CRT-D
- 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
- Electrophysiology
- CRT-D
- 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
- Electrophysiology
- Defibrillators
- Implantable Cardioverter Defibrillator (ICD)
- 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
- Electrophysiology
- Defibrillators
- Implantable Cardioverter Defibrillator (ICD)
- 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
- Interventional Cardiology
- Vascular Surgery
- Interventional Radiology
- Plaque Modification
- 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
- Interventional Cardiology
- Interventional Radiology
- Vascular Surgery
- Plaque Modification
- 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
- Electrophysiology
- Pacemakers
- Leads
- Clinical Summaries
-
Spectra WaveWriter™ Information for Prescribers
Jan 04, 2018
PDF( 838.0 KB )
Model(s): SC-1160
Part Number: 91171759-02
Safety Related Revision? No
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- 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
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- Directions for Use
-
Stingray™ - Directions For Use
Aug 01, 2014
Catheter
PDF( 67.0 KB )
Part Number: 90981782-01A
Safety Related Revision? No
- Interventional Cardiology
- CTO Systems
- 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
- Interventional Cardiology
- CTO Systems
- Directions for Use
-
Stingray™ - Directions for Use
Jul 01, 2017
Extension Wire
PDF( 47.0 KB )
Part Number: 50526084-01A
Safety Related Revision? No
- Interventional Cardiology
- CTO Systems
- 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
- Electrophysiology
- CRT-D
- Implantable Cardioverter Defibrillator (ICD)
- Supplemental Updates
- 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
- Neurological Surgery
- Deep Brain Stimulator Systems
- 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
- Pain Medicine
- Orthopaedic Surgery
- Neurological Surgery
- Spinal Cord Stimulator Systems
- 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
- Gynecology
- Surgical Gynecology
- Urology
- Uterine Tissue Removal Systems
- 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
- Urology
- Gynecology
- Surgical Gynecology
- Uterine Tissue Removal Systems
- 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
- Interventional Cardiology
- Stents Coronary
- 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
- Interventional Cardiology
- Stents Coronary
- 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
- Interventional Cardiology
- Stents Coronary
- 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
- Interventional Cardiology
- Stents Coronary
- 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
- Interventional Cardiology
- Stents Coronary
- 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
- Interventional Cardiology
- Stents Coronary
- 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
- Interventional Cardiology
- Stents Coronary
- 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
- Interventional Cardiology
- Stents Coronary
- 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
- Interventional Cardiology
- Catheters Balloon
- 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
- Interventional Cardiology
- Vascular Surgery
- Interventional Radiology
- CTO Systems
- 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
- Interventional Cardiology
- Vascular Surgery
- Interventional Radiology
- CTO Systems
- 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
- Interventional Cardiology
- Catheters Diagnostic
- 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
- Electrophysiology
- CRT-D
- CRT-P
- Pacemakers
- Integration Guides
-
- Electrophysiology
- Implantable Cardioverter Defibrillator (ICD)
- 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
- Electrophysiology
- Implantable Cardioverter Defibrillator (ICD)
- Reference Guides
-
Vercise™ DBS Charger Handbook
Sep 07, 2017
PDF( 1.0 MB )
Part Number: 92093582-01
Safety Related Revision? No
- Neurological Surgery
- Deep Brain Stimulator Systems
- Directions for Use
-
Vercise™ DBS Physician Manual
Dec 08, 2017
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: 92093580-01 Rev E
Safety Related Revision? No
- Neurological Surgery
- Deep Brain Stimulator Systems
- 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
- Neurological Surgery
- Deep Brain Stimulator Systems
- Directions for Use
-
Vercise™ M8 Adapter DFU
Nov 17, 2017
PDF( 371.0 KB )
Model(s): DB-9218-15, DB-9218-55
Part Number: 92093578-01 Rev C
Safety Related Revision? No
- Neurological Surgery
- Deep Brain Stimulator Systems
- Directions for Use
-
Vercise™ Patient Manual
Dec 11, 2017
PDF( 2.0 MB )
Part Number: 92093579-01
Safety Related Revision? No
- Neurological Surgery
- Deep Brain Stimulator Systems
- 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
- Interventional Cardiology
- Stents Coronary
- 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
- Interventional Cardiology
- Stents Coronary
- Patient Information
-
VISIONIST™ VISIONIST™ X4 VALITUDE™ VALITUDE™ X4 INTUA™ INVIVE™ - REFERENCE GUIDE
May 01, 2016
CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER
PDF( 3.0 MB )
Model(s): U225, U226, U228, U125, U128, V272, V273, V172, V173
Part Number: 359242-002
Safety Related Revision? No
- Electrophysiology
- CRT-P
- Reference Guides
-
VISIONIST™, VISIONIST™ X4, VALITUDE™, VALITUDE™ X4, INTUA™, INVIVE™ - PHYSICIAN’S TECHNICAL MANUAL
Apr 01, 2016
CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER
PDF( 491.0 KB )
Model(s): U225, U226, U228, U125, U128, V272, V273, V172, V173
Part Number: 359252-002
Safety Related Revision? No
- Electrophysiology
- CRT-P
- Directions for Use
-
- Electrophysiology
- CRT-D
- Implantable Cardioverter Defibrillator (ICD)
- Clinical Summaries
-
- Electrophysiology
- Implantable Cardioverter Defibrillator (ICD)
- 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
- Electrophysiology
- Implantable Cardioverter Defibrillator (ICD)
- 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
- Vascular Surgery
- Stents Vascular
- 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
- Interventional Cardiology
- Left Atrial Appendage Closure System
- 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
- Interventional Cardiology
- Left Atrial Appendage Closure System
- 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
- Interventional Cardiology
- Left Atrial Appendage Closure System
- Patient Information
-
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
- Electrophysiology
- Leads
- 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
- Interventional Cardiology
- Plaque Modification
- Directions for Use
-
Your ImageReady™ MR Conditional Pacing System and MRI Scans
Jul 01, 2014
PDF( 65.0 KB )
Part Number: 359260-001
- Electrophysiology
- Pacemakers
- Leads
- 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
- Electrophysiology
- Remote Patient Monitoring
- 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
- Electrophysiology
- Remote Patient Monitoring
- Supplemental Updates
- Programming and Operator's Manuals