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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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This website contains product literature for many, but not all, of Boston Scientific’s products.
Product literature varies by geography. Use only product literature from the region where the patient procedure is performed.
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ELUVIA™ - Directions for Use

Sep 01, 2018

Drug-Eluting Vascular Stent System

PDF( 248.0 KB )

Part Number: 50565157-01A
Boston Scientific DBS Reference Guide

Aug 27, 2018

PDF( 148.0 KB )

Part Number: 92094272-07

Safety Related Revision? No
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
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
ELUVIA™ - Patient Information Guide,

Aug 01, 2018

Drug-Eluting Vascular Stent System

PDF( 3.0 MB )

Part Number: 50731172-03A
Boston Scientific Spinal Cord Stimulator (SCS) Systems Reference Guide

Jul 17, 2018

PDF( 550.0 KB )

Part Number: 91005942-07

Safety Related Revision? No
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
Promus ELITE™ - Directions for Use

Jul 01, 2018

Everolimus-Eluting Platinum Chromium Coronary Stent System

PDF( 481.0 KB )

Part Number: 50493043-01B
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
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
Promus ELITE™ - Patient Information Guide

Jun 01, 2018

Everolimus-Eluting Platinum Chromium Coronary Stent System

PDF( 159.0 KB )

Part Number: 50589644-02B
REBEL® - Directions for Use

Jun 01, 2018

Platinum Chromium Coronary Stent System

PDF( 135.0 KB )

Part Number: 50673276-01A

Safety Related Revision? No
Ultra ICE™ Plus - PI - Directions for Use

May 01, 2018

Peripheral Imaging Catheter

PDF( 170.0 KB )

Part Number: 50677333-01A
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
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
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
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
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
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
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
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
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
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
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
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
"Bionic Navigator™ 1.2 Software Guide"

Jan 05, 2018

PDF( 2.0 MB )

Model(s): SC-1160

Part Number: 91171765-02
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
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
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
Precision Spectra™ Information for Prescribers

Jan 04, 2018

PDF( 837.0 KB )

Model(s): SC-1132

Part Number: 91008787-03

Safety Related Revision? No
Spectra WaveWriter™ Information for Prescribers

Jan 04, 2018

PDF( 838.0 KB )

Model(s): SC-1160

Part Number: 91171759-02

Safety Related Revision? No
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
Blazer™ Open-Irrigated - Directions for Use

Jan 01, 2018

Ablation Catheter

PDF( 406.0 KB )

Part Number: 50463687-01A

Safety Related Revision? No
IntellaNav MiFi™ Open-Irrigated - Directions for Use

Jan 01, 2018

Ablation Catheter

PDF( 175.0 KB )

Part Number: 50585456-01A

Safety Related Revision? No
IntellaNav™ Open-Irrigated - Directions for Use

Jan 01, 2018

Ablation Catheter

PDF( 429.0 KB )

Part Number: 50463690-01A

Safety Related Revision? No
IntellaNav™ ST - Directions for Use

Jan 01, 2018

Ablation Catheter

PDF( 277.0 KB )

Part Number: 50476382-01B
IntellaTip MiFi™ Open-Irrigated - Directions for Use

Jan 01, 2018

Ablation Catheter

PDF( 175.0 KB )

Part Number: 50585524-01A

Safety Related Revision? No
Precision Novi™ Information for Presribers

Jan 01, 2018

PDF( 969.0 KB )

Model(s): SC-1140

Part Number: 91005929-02

Safety Related Revision? No
WATCHMAN™ TruSeal™ Access System - Directions for Use

Jan 01, 2018

Access Sheath with Dilator

PDF( 47.0 KB )

Part Number: 50533907-01A
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
Vercise™ Patient Manual

Dec 11, 2017

PDF( 2.0 MB )

Part Number: 92093579-01

Safety Related Revision? No
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
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
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
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
Symphion™ - Directions For Use

Dec 01, 2017

Tissue Removal System

PDF( 1.0 MB )

Part Number: 91061461-01B

Safety Related Revision? No
Symphion™ - Directions For Use

Dec 01, 2017

6.3 Endoscope

PDF( 430.0 KB )

Part Number: 91061524-01

Safety Related Revision? No
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
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
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
FilterWire EZ™ - Directions for Use

Nov 01, 2017

Embolic Protection System

PDF( 797.0 KB )

Part Number: 50606897-01A

Safety Related Revision? No
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
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
LATITUDE™ PROGRAMMING SYSTEM - OPERATOR’S MANUAL

Oct 01, 2017

PDF( 2.0 MB )

Model(s): 3300

Part Number: 359487-002
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
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
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
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
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
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
Vercise™ DBS Charger Handbook

Sep 07, 2017

PDF( 1.0 MB )

Part Number: 92093582-01

Safety Related Revision? No
AMS™ Disposable Dilators - Instructions for Use

Sep 01, 2017

PDF( 273.0 KB )

Part Number: 92130122-01A

Safety Related Revision? No
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
ENABLE MRI - CLINICAL STUDY SUMMARY

Sep 01, 2017

PDF( 173.0 KB )

Part Number: 92082300-001
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
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
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
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
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
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
EMBLEM™ S-ICD - Patient Handbook

Aug 01, 2017

PDF( 2.0 MB )

Part Number: 359284-004

Safety Related Revision? No
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
EMBLEM™ S-ICD - USER’S MANUAL

Aug 01, 2017

Electrode Delivery System

PDF( 757.0 KB )

Model(s): 4712

Part Number: 360244-001
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
EMBLEM™ S-ICD - USER’S MANUAL

Aug 01, 2017

Subcutaneous Electrode

PDF( 425.0 KB )

Model(s): 3501

Part Number: 360213-002
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
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
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
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
Stingray™ - Directions for Use

Jul 01, 2017

Guidewire with Hydrophilic Coating

PDF( 131.0 KB )

Part Number: 50526083-01A

Safety Related Revision? No
Stingray™ - Directions for Use

Jul 01, 2017

Extension Wire

PDF( 47.0 KB )

Part Number: 50526084-01A

Safety Related Revision? No
Reference Guide

Jun 12, 2017

PDF( 552.0 KB )

Part Number: 91005942-06

Safety Related Revision? No
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
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
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
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
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
LATITUDE Consult™ System - CLINICIAN USER MANUAL

May 01, 2017

PDF( 3.0 MB )

Model(s): 6299

Part Number: 359165-004

Safety Related Revision? No
Limited Warranty

May 01, 2017

PDF( 190.0 KB )

Part Number: 91006760-01 REV D

Safety Related Revision? No
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
Precision Spectra™ OMG

May 01, 2017

PDF( 177.0 KB )

Part Number: 91171773-01 REV A

Safety Related Revision? No
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
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
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
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
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
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
IntellaNav MiFi™ XP - Directions for Use

Apr 01, 2017

Temperature Ablation Catheter, Based on: Boston Scientific, Master Brand DFU Template 8.5 x 11.6929, 90105918 Rev/Ver. AA

PDF( 270.0 KB )

Part Number: 90874002-01C

Safety Related Revision? No
IntellaNav™ XP - Directions for Use

Apr 01, 2017

Temperature Ablation Catheter, Based on: Boston Scientific, Master Brand DFU Template 8.5 x 11.6929, 90105918 Rev/Ver. AA

PDF( 269.0 KB )

Part Number: 90902676-01C

Safety Related Revision? No
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
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
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
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
Connecting to Nevro Leads

Mar 01, 2017

PDF( 213.0 KB )

Part Number: 91131569-01

Safety Related Revision? No
CRT-D - Patient Handbook

Mar 01, 2017

Cardiac Resynchronization Therapy Defibrillator

PDF( 3.0 MB )

Part Number: 356965-008
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
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
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
ICD - Patient Handbook

Mar 01, 2017

Implantable Cardioverter Defibrillator Therapy

PDF( 3.0 MB )

Part Number: 356434-011
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
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
ImageReady™ MR Conditional Defibrillation System - Patient Guide for MRI Scans

Feb 01, 2017

PDF( 66.0 KB )

Part Number: 92082295-001
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
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
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
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
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
Express™ LD - Patient Information Guide

Sep 01, 2016

Iliac Premounted Stent System

PDF( 300.0 KB )

Part Number: 50417990-02A

Safety Related Revision? No
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
PROMUS Element™ Plus - Directions For Use

Sep 01, 2016

Everolimus-Eluting Platinum Chromium Coronary Stent System

PDF( 471.0 KB )

Part Number: 50417771-01A
Promus PREMIER™ - Directions for Use

Sep 01, 2016

Everolimus-Eluting Platinum Chromium Coronary Stent System

PDF( 523.0 KB )

Part Number: 50417770-01A
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
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
LATITUDE™ Communicator - PATIENT MANUAL

Aug 01, 2016

PDF( 6.0 MB )

Model(s): 6280, 6290

Part Number: 359371-002

Safety Related Revision? No
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
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
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
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
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
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
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
Ultra ICE™ Plus - Directions For Use

May 01, 2016

9 MHz IntraCardiac Echo Catheter

PDF( 191.0 KB )

Part Number: 91040401-01B
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
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
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
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
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
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
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
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
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
Programming Wand

Jan 20, 2016

PDF( 225.0 KB )

Model(s): NM-7190

Part Number: 91008426-02 REV A

Safety Related Revision? No
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
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
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
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
LATITUDE® Communicator Important Information

Nov 01, 2015

PDF( 48.0 KB )

Model(s): 6280, 6290

Part Number: 358080-001

Safety Related Revision? No
OptiCross™ 6 - Directions for Use

Nov 01, 2015

40 MHz Coronary Imaging Catheter

PDF( 229.0 KB )

Model(s): H7495181160

Part Number: 91062654-01A
Labeling Symbols

Oct 30, 2015

PDF( 565.0 KB )

Part Number: 91006762-01 REV C

Safety Related Revision? No
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
Clik X Anchor

Sep 29, 2015

PDF( 447.0 KB )

Model(s): SC-4318

Part Number: 91030578-01 REV C

Safety Related Revision? No
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
Labeling Symbols

Aug 29, 2015

PDF( 180.0 KB )

Part Number: 91006762-01 REV B

Safety Related Revision? No
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
Precision Spectra IPG

Aug 29, 2015

PDF( 895.0 KB )

Model(s): SC-1132

Part Number: 91057051-01 REV A

Safety Related Revision? No
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
ImageReady™ MR Conditional S-ICD System - Patient Guide for MRI Scans

Aug 01, 2015

PDF( 61.0 KB )

Part Number: 359477-001
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
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
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
Innova™ - Understanding Peripheral Artery Disease - Patient Information Guide

Jul 01, 2015

Vascular Self-Expanding Stent System

PDF( 2.0 MB )

Part Number: 91062177-02A
Innova™ Vascular OVER-THE-WIRE - Directions For Use

Jul 01, 2015

Self-Expanding Stent System

PDF( 305.0 KB )

Part Number: 90958202-01B
NC Emerge® - Directions For Use

Jul 01, 2015

PTCA Dilatation Catheter

PDF( 77.0 KB )

Part Number: 91074307-01A

Safety Related Revision? No
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
Blazer® II Blazer® II HTD - Directions For Use

May 01, 2015

Temperature Ablation Catheters

PDF( 175.0 KB )

Part Number: 90927318-01C
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
IntellaTip MiFi™ XP Directions For Use

May 01, 2015

Temperature Ablation Catheter

PDF( 233.0 KB )

Part Number: 90948431-01B
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
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
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
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
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
Blazer Prime® HTD - Directions For Use

Jan 01, 2015

Temperature Ablation Catheters

PDF( 156.0 KB )

Part Number: 90927309-01A
Blazer Prime® XP - Directions For Use

Jan 01, 2015

Temperature Ablation Catheter

PDF( 211.0 KB )

Part Number: 90927316-01A
Blazer® II XP - Directions For Use

Jan 01, 2015

Temperature Ablation Catheter

PDF( 211.0 KB )

Part Number: 90927317-01A
Chilli II® - Directions For Use

Jan 01, 2015

Cooled Ablation Catheter

PDF( 207.0 KB )

Part Number: 90927230-01A
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
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
Promus PREMIER™ - Patient Information Guide

Dec 01, 2014

Everolimus-Eluting Platinum Chromium Coronary Stent System

PDF( 125.0 KB )

Part Number: 90996662-02A
REBEL™ - Patient Information Guide

Dec 01, 2014

Platinum Chromium Coronary Stent System

PDF( 116.0 KB )

Part Number: 90991555-02A

Safety Related Revision? No
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
Genesys HTA ProCerva™ - Directions For Use

Oct 01, 2014

Procedure Set

PDF( 325.0 KB )

Part Number: 90990402-01A

Safety Related Revision? No
Emerge™ - Directions for Use

Sep 01, 2014

PTCA Dilatation Catheter

PDF( 82.0 KB )

Part Number: 90990229-01A

Safety Related Revision? No
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
Epic™ Vascular - Directions For Use

Sep 01, 2014

Self-Expanding Stent System

PDF( 224.0 KB )

Part Number: 90984760-01A

Safety Related Revision? No
OptiCross™ - Directions For Use

Sep 01, 2014

40 MHz Coronary Imaging Catheter

PDF( 209.0 KB )

Part Number: 90986247-01A

Safety Related Revision? No
LATITUDE® - Clinician Manual

Aug 14, 2014

LATITUDE® Patient Management System

PDF( 2.0 MB )

Model(s): 6488

Part Number: 357242-017
LATITUDE® - Integration 2.01 Guide

Aug 14, 2014

LATITUDE® Patient Management System

PDF( 1.0 MB )

Model(s): 6464, 6497

Part Number: 358549-002
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
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
ACUITY® Pro - Directions For Use

Aug 01, 2014

9F Guide Catheter

PDF( 130.0 KB )

Part Number: 90981810-01A

Safety Related Revision? No
ACUITY® Pro - Directions For Use

Aug 01, 2014

7F Guide Catheter

PDF( 61.0 KB )

Part Number: 90981811-01A

Safety Related Revision? No
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
CrossBoss™ - Directions For Use

Aug 01, 2014

Catheter

PDF( 65.0 KB )

Part Number: 90981783-01A

Safety Related Revision? No
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
Pacemaker Therapy

Aug 01, 2014

PDF( 656.0 KB )

Part Number: 356429-010
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
Stingray™ - Directions For Use

Aug 01, 2014

Catheter

PDF( 67.0 KB )

Part Number: 90981782-01A

Safety Related Revision? No
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
Threader™ - Directions for Use

Jul 01, 2014

Micro-Dilatation Catheter

PDF( 117.0 KB )

Part Number: 90939120-01B

Safety Related Revision? Not-Applicable
Your ImageReady™ MR Conditional Pacing System and MRI Scans

Jul 01, 2014

PDF( 65.0 KB )

Part Number: 359260-001
Guide to Replacement of Cardiac Implantable Pulse Generators

May 14, 2014

PDF( 2.0 MB )

Part Number: 358331-002
ZOOM® LATITUDE® - OPERATOR’S MANUAL

Apr 29, 2014

Programmer/Recorder/Monitor

PDF( 7.0 MB )

Model(s): 3120

Part Number: 357434-009
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
CRT-P - Patient Handbook

Apr 01, 2014

Cardiac Resynchronization Therapy

PDF( 3.0 MB )

Part Number: 356430-007

Safety Related Revision? No
LATITUDE™ Communicator - Patient Manual Supplement

Mar 01, 2014

LATITUDE™ Patient Management System

PDF( 5.0 MB )

Model(s): 6293

Part Number: 359337-001
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
IVORY STUDY - Clinical Summary

Jul 24, 2013

PDF( 97.0 KB )

Part Number: 358487-019
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
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
ZOOM® LATITUDE® - Operator’s Manual Supplement

Mar 04, 2013

Programmer/Recorder/Monitor

PDF( 177.0 KB )

Model(s): 3120

Part Number: 359065-002
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
LATITUDE® Communicator Patient Manual Supplement

Aug 01, 2012

Analog-to-Wireless Converter

PDF( 1.0 MB )

Model(s): 6456

Part Number: 358829-001
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
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
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
COGNATE STUDY - Clinical Summary

May 02, 2012

PDF( 111.0 KB )

Part Number: 358487-016
CONTAK RENEWAL HOLTER STUDY - Clinical Summary

May 02, 2012

PDF( 87.0 KB )

Part Number: 358487-017
INSIGNIA I ULTRA STUDY - Clinical Summary

May 02, 2012

PDF( 90.0 KB )

Part Number: 358487-014
PULSAR MAX STUDY - Clinical Summary

May 02, 2012

PDF( 99.0 KB )

Part Number: 358487-015
TruePath™ CTO Device - Directions for Use

Jan 01, 2012

CTO Device

PDF( 210.0 KB )

Part Number: 90741285-01A

Safety Related Revision? Not-Applicable
TruePath™ Extension Wire - Directions for Use

Jan 01, 2012

Extension Wire

PDF( 53.0 KB )

Part Number: 90732646-01A

Safety Related Revision? Not-Applicable
COGENT-4 FIELD FOLLOWING STUDY - Clinical Summary

Nov 23, 2011

PDF( 195.0 KB )

Part Number: 358487-012
COMPANION - Clinical Summary

Nov 23, 2011

PDF( 667.0 KB )

Part Number: 358487-001
CONTAK CD - Clinical Summary

Nov 23, 2011

PDF( 802.0 KB )

Part Number: 358487-006
CONTAK RENEWAL - Clinical Summary

Nov 23, 2011

PDF( 112.0 KB )

Part Number: 358487-007
CONTAK RENEWAL 3 AVT - Clinical Summary

Nov 23, 2011

PDF( 164.0 KB )

Part Number: 358487-011
CRT OPTIMIZATION ALGORITHM - Clinical Summary

Nov 23, 2011

PDF( 393.0 KB )

Part Number: 358487-003
DECREASE-HF - Clinical Summary

Nov 23, 2011

PDF( 183.0 KB )

Part Number: 358487-002
GDT1000 SENSING ACUTE STUDY - Clinical Summary

Nov 23, 2011

PDF( 116.0 KB )

Part Number: 358487-005
MADIT-CRT - Clinical Summary

Nov 23, 2011

PDF( 1.0 MB )

Part Number: 358487-013
MADIT-II - Clinical Summary

Nov 23, 2011

PDF( 256.0 KB )

Part Number: 358487-004
VENTAK AV II - Clinical Summary

Nov 23, 2011

PDF( 101.0 KB )

Part Number: 358487-008
VITALITY - Clinical Summary

Nov 23, 2011

PDF( 99.0 KB )

Part Number: 358487-009
VITALITY DS - Clinical Summary

Nov 23, 2011

PDF( 91.0 KB )

Part Number: 358487-010
Gladiator™ - Directions for Use

Oct 01, 2011

PTA Balloon Dilatation Catheter

PDF( 60.0 KB )

Part Number: 90657937-01B

Safety Related Revision? Not-Applicable
PROMUS™ - Instructions for Use

May 19, 2011

Everolimus-Eluting Coronary Stent System

PDF( 531.0 KB )

Part Number: EL2078399

Safety Related Revision? Not-Applicable
PROMUS® - Patient Information Guide

May 18, 2011

Everolimus-Eluting Coronary Stent System

PDF( 399.0 KB )

Part Number: EL2077745

Safety Related Revision? Not-Applicable
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
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
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
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
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
ALTRUA™ 60 - System Guide

Jan 05, 2011

Multiprogrammable Pacemakers

PDF( 4.0 MB )

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

Part Number: 357921-003
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
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
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
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
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
LATITUDE® Patient Management - EMR Integration Security Certificate Installation & Configuration

Jan 05, 2011

PDF( 278.0 KB )

Part Number: 357735-003
LATITUDE® Patient Management - EMR Integration Testing Scenarios

Jan 05, 2011

PDF( 288.0 KB )

Part Number: 357742-003
Lead Delivery System Accessory Kit, IS-1 - Instructions for Use

Jan 05, 2011

PDF( 100.0 KB )

Model(s): 7611

Part Number: EL2045594
Lead Delivery System Accessory Kit, LV-1 - Instructions for Use

Jan 05, 2011

PDF( 66.0 KB )

Model(s): 7610

Part Number: EL2045620
RAPIDO® - Instructions for Use

Jan 05, 2011

6F Guiding Catheter

PDF( 60.0 KB )

Model(s): 7720, 7721

Part Number: EL2045909
USB Data Management Utility

Jan 05, 2011

ZOOM® LATITUDE® Programming System

PDF( 4.0 MB )

Model(s): 3120

Part Number: 358471-001
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
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
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
LATITUDE® Patient Management - EMR Integration Technical Application Overview

Jan 04, 2011

PDF( 2.0 MB )

Part Number: 357729-003
RAPIDO® Cut-Away® - Instructions for Use

Jan 03, 2011

Guiding Catheter System

PDF( 236.0 KB )

Part Number: EL2045915
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
Clik Anchor

Dec 20, 2010

PDF( 379.0 KB )

Model(s): SC-4316

Part Number: 9055951-001 Rev AB

Safety Related Revision? No
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
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
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
Implantable Materials Kit

Apr 19, 2010

PDF( 35.0 KB )

Model(s): SC-4600

Part Number: 9055597-001 Rev B

Safety Related Revision? No
OMG™ Connector – A

Apr 19, 2010

PDF( 731.0 KB )

Model(s): SC-9305

Part Number: 9055568-002 Rev A

Safety Related Revision? No
OMG™ Connector – M

Apr 19, 2010

PDF( 703.0 KB )

Model(s): SC-9310

Part Number: 9055562-002 Rev A

Safety Related Revision? No
Precision Introducer Kit

Apr 19, 2010

PDF( 375.0 KB )

Model(s): SC-4365

Part Number: 9055579-002 Rev B

Safety Related Revision? No
Liberté® - Product Safety Information

Sep 18, 2009

Bare-Metal Coronary Stent System

PDF( 609.0 KB )

Safety Related Revision? Yes
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
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

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