United States (English)
Directions for Use and Product Manuals for Healthcare Professionals
These documents may change without notice; this website will always contain the most current version. Information included may not apply to all previous versions of product. Review manuals before using or implanting a device, or performing follow-up care.
The results listed below show only what is available for this region / language combination. Use the three filter settings below to reduce the list size.
PLEASE NOTE:
- 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.
- Some documents may not display well on mobile devices.
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DBS Reference Guide
Jul 21, 2020
Vercise ™ RC, Vercise ™ PC and Vercise Gevia ™ DBS Systems
PDF( 191.0 KB )
Model(s): DB-1200, DB-1110-C, DB-1140, DB-2201-30-DC, DB-2201-45-DC, DB-2201-30-AC DB-2201-45-BC DB-2202-30 DB-2202-45 NM-3138-55 DB-4600-C DB-9418-15 DB-9218-15 DB-9218-55 DB-5132 DB-5110-C DB-9315 SC-4108 and DB-4108 SC-4100-A and DB-4100-A DB-2500-C DB-4605-C SC-4252 SC-4254 DB-5552-1A DB-5500-C DB-5212-C DB-5250 NM-6210 NM-6315 NM-6600 DB-64125 DB-6300-C DB-6200-C DB-6100-C NM-6350 NM-5312 NM-5305 NM-6305 NM-3100 DB-7161 and NM-7161 DB-7161-R and NM-7161-R DB‑7164 and NM‑7164 DB‑7164-R and NM‑7164-R DB-7105-N21 DB-7105-N21‑W10 DB-7105-N31 DB-7105-N31‑W10 NM-7190 and DB-7190 NM-6316 DB-7162 and NM-7162 NM‑7165 NM-7113 NM-6317 NM‑7171 DB‑7101‑204 DB‑7101‑204‑W10 NM-4500 DB-4511 NM-4502 DB-7154 DB-7104 DB-7114 DB-7124"
Part Number: 92094272-11
Safety Related Revision? No
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Vercise Neural Navigator 3 (Windows 10) Programming Manual
Jul 21, 2020
Vercise ™ PC and Vercise Gevia ™ DBS Systems
PDF( 3.0 MB )
Model(s): DB-7105-N31-W10
Part Number: 92376212-02
Safety Related Revision? No
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Vercise Neural Navigator 3.1 (Windows 10) Installation Guide
Jul 21, 2020
Vercise ™ PC and Vercise Gevia ™ DBS Systems
PDF( 1.0 MB )
Model(s): DB-7105-N31-W10
Part Number: 92375868-02
Safety Related Revision? No
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USER’S MANUAL LUX-Dx™
Jul 01, 2020
Insertable Cardiac Monitor System
PDF( 4.0 MB )
Model(s): M301, 2925, 2935
Part Number: 92216689-002
Safety Related Revision? No
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WATCHMAN FLX™ - Directions for Use
Jul 01, 2020
Left Atrial Appendage Closure Device with Delivery System
PDF( 613.0 KB )
Model(s): M635WU50200, M635WU50240, M635WU50270, M635WU50310, M635WU50350
Part Number: 50816633 -01A
Safety Related Revision? No
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WATCHMAN FLX™- Patient Information Guide
Jul 01, 2020
Left Atrial Appendage Closure Device
PDF( 247.0 KB )
Model(s): M635WU50200, M635WU50240, M635WU50270, M635WU50310, M635WU50350
Part Number: 50817794-01A
Safety Related Revision? No
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WATCHMAN® - Directions for Use
Jul 01, 2020
Left Atrial Appendage Closure Device with Delivery System
PDF( 294.0 KB )
Model(s): M635WU21060, M635WU24060, M635WU27060, M635WU30060, M635WU33060
Part Number: 51170107-01A
Safety Related Revision? No
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Bionic Navigator 2.04 (Windows 10) Programming Manual
Jun 18, 2020
Vercise ™ RC DBS System
PDF( 4.0 MB )
Model(s): DB-7101-204-W10
Part Number: 92161115-02
Safety Related Revision? No
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LATITUDE™ Programming System - OPERATOR’S MANUAL
Jun 01, 2020
PDF( 34.0 MB )
Model(s): 3300
Part Number: 359487-007
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OptiCross™ 35 - Directions for Use
Jun 01, 2020
Peripheral Imaging Catheter
PDF( 203.0 KB )
Model(s): H7493932800350
Part Number: 50644851-01B
Safety Related Revision? No
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SYNERGY™ XD- Directions for Use
Jun 01, 2020
Everolimus-Eluting Platinum Chromium Coronary Stent System
PDF( 179.0 KB )
Model(s): H7493941808220; H7493941808250; H7493941808270; H7493941808300; H7493941808350; H7493941808400; H7493941812220; H7493941812250; H7493941812270; H7493941812300; H7493941812350; H7493941812400; H7493941812450; H7493941812500; H7493941816220; H7493941816250; H7493941816270; H7493941816300; H7493941816350; H7493941816400; H7493941816450; H7493941816500; H7493941820220; H7493941820250; H7493941820270; H7493941820300; H7493941820350; H7493941820400; H7493941820450; H7493941820500; H7493941824220; H7493941824250; H7493941824270; H7493941824300; H7493941824350; H7493941824400; H7493941824450; H7493941824500; H7493941828220; H7493941828250; H7493941828270; H7493941828300; H7493941828350; H7493941828400; H7493941828450; H7493941828500; H7493941832220; H7493941832250; H7493941832270; H7493941832300; H7493941832350; H7493941832400; H7493941832450; H7493941832500; H7493941838220; H7493941838250; H7493941838270; H7493941838300; H7493941838350; H7493941838400; H7493941848250; H7493941848270; H7493941848300; H7493941848350; H7493941848400
Part Number: 50815660-01B
Safety Related Revision? No
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Coventor Adult Manual Resuscitator Compressor-IFU
Apr 28, 2020
IFU, Coventor
PDF( 735.0 KB )
Model(s): H74939379010
Part Number: 51129138-01C
Safety Related Revision? No
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Bionic Navigator 2.04 (Windows 10) Installation Guide
Apr 20, 2020
Vercise ™ RC DBS System
PDF( 1.0 MB )
Model(s): DB-7101-204-W10
Part Number: 92161116-03
Safety Related Revision? No
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Vercise Neural Navigator 3 Programming Manual
Apr 15, 2020
Vercise™ PC and Vercise Gevia™ DBS Systems
PDF( 4.0 MB )
Model(s): M365DB7105N310
Part Number: 92376212-01
Safety Related Revision? No
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AVVIGO™ - User Manual
Apr 01, 2020
GUIDANCE SYSTEM
PDF( 24.0 MB )
Model(s): H7490097610, H749009761Z0, H749009761D0, H749009761R0
Part Number: 51033423-01A
Safety Related Revision? No
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IntellaNav MiFi™ Open-Irrigated – Directions for Use
Apr 01, 2020
Ablation Catheter
PDF( 990.0 KB )
Model(s): M004PMR96200, M004PMR9620K20, M004PMR9620N40
Part Number: 50868779-01
Safety Related Revision? No
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Superion® Indirect Decompression System
Mar 30, 2020
Implant Manual
PDF( 2.0 MB )
Model(s): 101-9808, 101-9810, 101-9812, 101-9814, 101-9816
Part Number: 92479815-01
Safety Related Revision? No
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Superion® Instrument Platform
Mar 30, 2020
Instrument Manual
PDF( 154.0 KB )
Model(s): 102-9800, 140-9800
Part Number: 92479820-01
Safety Related Revision? No
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Superion® Surgical Technique
Mar 30, 2020
Surgical Technique Manual
PDF( 7.0 MB )
Model(s): 101-9808, 101-9810, 101-9812, 101-9814, 101-9816, 140-9800, 102-9800
Part Number: 92479821-01
Safety Related Revision? No
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Agile Esophageal Fully Covered - Directions for Use
Mar 01, 2020
Stent System
PDF( 112.0 KB )
Model(s): M00517400, M00517410, M00517420, M00517430, M00517440, M00517450, M00517460, M00517470
Part Number: 51097881-01A
Safety Related Revision? No
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Agile Esophageal Partially Covered - Directions for Use
Mar 01, 2020
Stent System
PDF( 130.0 KB )
Model(s): M00517200, M00517210, M00517220, M00517230, M00517240, M00517250, M00517260, M00517270
Part Number: 51097879 -01A
Safety Related Revision? No
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VENOUS WALLSTENT™ - Directions for Use
Mar 01, 2020
Self-Expanding Stent
PDF( 169.0 KB )
Model(s): NA
Part Number: 50607601-01B
Safety Related Revision? No
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VENOUS WALLSTENT™ - Patient Information Guide
Mar 01, 2020
Self-Expanding Stent
PDF( 3.0 MB )
Model(s): NA
Part Number: 51105821-02A
Safety Related Revision? No
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EMBLEM™ S-ICD APPLICATION - OPERATOR'S MANUAL
Feb 01, 2020
for the LATITUDE™ Programming System
PDF( 18.0 MB )
Model(s): 3300, 3877
Part Number: 92123951-001
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PROMUS Element™ Plus - Directions for Use
Feb 01, 2020
Everolimus-Eluting Platinum Chromium Coronary Stent System
PDF( 462.0 KB )
Part Number: 50920153-01A
Safety Related Revision? No
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Symphion™ - Directions for Use (Applicable to Software Version 2.1.1)
Feb 01, 2020
Tissue Removal System
PDF( 1005.0 KB )
Model(s): FG-0612
Part Number: 50719398-01C
Safety Related Revision? No
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Boston Scientific DBS Reference Guide
Jan 02, 2020
Vercise™ PC and Vercise Gevia™ DBS Systems
PDF( 385.0 KB )
Model(s): M365DB7105N310
Part Number: 92094272-10
Safety Related Revision? No
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EXALT™ Accessories - User Manual
Jan 01, 2020
User Manual
PDF( 617.0 KB )
Part Number: 50991951-01 Rev B
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MODEL 3877 EMBLEM™ S-ICD SYSTEM APPLICATION* SUPPLEMENT FOR PULSE GENERATOR MANUALS - S-ICD PHYSICIAN’S TECHNICAL MANUALS
Jan 01, 2020
*FOR THE LATITUDE™ PROGRAMMING SYSTEM, MODEL 3300
PDF( 411.0 KB )
Model(s): 3200, 3300, 3877
Part Number: 92123954-001
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Promus ELITE™ - Directions for Use
Jan 01, 2020
Everolimus-Eluting Platinum Chromium Coronary Stent System
PDF( 507.0 KB )
Part Number: 50920154-01A
Safety Related Revision? No
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Promus PREMIER™ - Directions for Use
Jan 01, 2020
Everolimus-Eluting Platinum Chromium Coronary Stent System
PDF( 508.0 KB )
Part Number: 50920152-01A
Safety Related Revision? No
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SENTINEL™ - Directions for Use
Jan 01, 2020
Cerebral Protection System
PDF( 240.0 KB )
Model(s): CMS15-10C-US
Part Number: 51025501-01A
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ALTRUA™ 20 ALTRUA™ 40 ALTRUA™ 60 INSIGNIA™ I Entra INSIGNIA™ I Plus INSIGNIA™ I Ultra PaceMaker - REFERENCE GUIDE
Dec 01, 2019
PDF( 3.0 MB )
Model(s): S201, S203, S204, S205, S208 S401, S402, S403, S404 S601, S602, S603, S604, S605, S606 1195, 1198, 1294, 1295, 1296 1194, 1297, 1298 1190, 1290, 1291
Part Number: 92453608-001
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AMS Ambicor™ - Instructions for Use
Dec 01, 2019
Penile Prosthesis
PDF( 490.0 KB )
Model(s): 72401450, 72401451, 72401452, 72401453, 72401454, 72401455, 72401456, 72401457, 72401458
Part Number: 92113093-01B
Safety Related Revision? No
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AMS Ambicor™ - Operating Room Manual
Dec 01, 2019
Penile Prosthesis
PDF( 1.0 MB )
Model(s): 72401450, 72401451, 72401452, 72401453, 72401454, 72401455, 72401456, 72401457, 72401458
Part Number: 22000018-MH_K
Safety Related Revision? No
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CXR Rear Tip Extender (RTE) Kit - Instructions for Use
Dec 01, 2019
Rear Tip Extender Kit
PDF( 120.0 KB )
Model(s): 72403872, 72404320, 72404321, 72404322, 72404323, 72404330
Part Number: 230129-01-MHD
Safety Related Revision? No
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CXR Rear Tip Extender (RTE) Kit - Instructions for Use
Dec 01, 2019
Rear Tip Extender Kit
PDF( 89.0 KB )
Model(s): 72404043, 72404324, 72404325, 72404326
Part Number: 230132-01-MHD
Safety Related Revision? No
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EXALT™ Controller - User's Manual
Dec 01, 2019
User's Manual
PDF( 426.0 KB )
Part Number: 50866131-01
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EXALT™ Model D - Directions for Use
Dec 01, 2019
Single-Use Duodenoscope
PDF( 251.0 KB )
Part Number: 50866130-01
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Bionic Navigator™ 1.2 (Win 10) Installation Guide
Nov 11, 2019
Bionic Navigator™ 1.2 (Win 10) Installation Guide
PDF( 1.0 MB )
Model(s): SC-7101-120-W10, NM-7164, NM-7164-R, DB-7164, DB-7164-R
Part Number: 92354013-01
Safety Related Revision? No
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Bionic Navigator™ 1.2 Software Guide
Nov 11, 2019
Bionic Navigator™ 1.2 Software Guide
PDF( 2.0 MB )
Model(s): SC-7101-120-W10, NM-7164, NM-7164-R, DB-7164, DB-7164-R, NM-7161, NM-7161-R, NM-7153-30, NM-7153-30R, NM-7153-11A, NM-7153-11AR
Part Number: 92357494-01
Safety Related Revision? No
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Bionic Navigator™ 3D 2.20 (Win 10) Installation Guide
Nov 11, 2019
Bionic Navigator™ 3D 2.20 (Win 10) Installation Guide
PDF( 1.0 MB )
Model(s): SC-7101-220-W10, NM-7164, NM-7164-R, DB-7164, DB-7164-R
Part Number: 92357490-01
Safety Related Revision? No
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Bionic Navigator™ 3D System Programming Manual
Nov 11, 2019
Bionic Navigator™ 3D System Programming Manual
PDF( 12.0 MB )
Model(s): SC-7101-220-W10, NM-7164, NM-7164-R, DB-7164, DB-7164-R, NM-7161, NM-7161-R, NM-7153-30, NM-7153-30R, NM-7153-11A, NM-7153-11AR
Part Number: 92357498-01
Safety Related Revision? No
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AMS Ambicor™ - Directions for Use
Nov 01, 2019
Inflatable Penile Prosthesis
PDF( 1003.0 KB )
Model(s): 72401450, 72401451, 72401452, 72401453, 72401454, 72401455, 72401456, 72401457, 72401458, 72402890
Part Number: 50654573-01C
Safety Related Revision? No
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Disposable Dilators - Directions for Use
Nov 01, 2019
Disposable Dilator
PDF( 118.0 KB )
Model(s): 720117-01
Part Number: 50654572-01B
Safety Related Revision? No
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LATITUDE™ - LATITUDE INTEGRATION IDCO SPECIFICATION
Nov 01, 2019
LATITUDE Patient Management System
PDF( 336.0 KB )
Model(s): 6455, 6624
Part Number: 92290289-001
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LATITUDE™ Communicator - PATIENT MANUAL
Nov 01, 2019
PDF( 2.0 MB )
Model(s): 6280, 6290
Part Number: 359371-007
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LATITUDE™ NXT - CLINICIAN MANUAL
Nov 01, 2019
LATITUDE NXT Patient Management System
PDF( 3.0 MB )
Model(s): 6460, 6280, 6290, 6498, 6476, 7260
Part Number: 358826-011
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LATITUDE™ NXT- LATITUDE INTEGRATION HL7 SPECIFICATION
Nov 01, 2019
LATITUDE NXT Patient Management System
PDF( 276.0 KB )
Model(s): 6455, 6624
Part Number: 92290311-001
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MRI TECHNICAL GUIDE IMAGEREADY™ MR Conditional Defibrillation System
Nov 01, 2019
PDF( 3.0 MB )
Model(s): D000, D001, D002, D003, D010, D011, D012, D013, D020, D021, D022, D023, D050, D051, D052, D053, D120, D121, D140, D141, D142, D143, D150, D151, D152, D153, D160, D161, D162, D163, D220, D221, D232, D233, D400, D401, D412, D413, D420, D421, D432, D433, D500, D501, D512, D513, D520, D521, D532, D533, G050, G051, G056, G058, G124, G125, G128, G138, G140, G141, G146, G148, G150, G151, G156, G158, G160, G161, G166, G168, G224, G225, G228, G237, G247, G248, G424, G425, G428, G437, G447, G448, G524, G525, G528, G537, G547, G548, 0127, 0128, 0129, 0137, 0138, 0139, 0143, 0147, 0148, 0149, 0153, 0157, 0158, 0159, 0170, 0171, 0172, 0173, 0174, 0175, 0176, 0177, 0180, 0181, 0182, 0183, 0184, 0185, 0186, 0187, 0262, 0263, 0265, 0266, 0272, 0273, 0275, 0276, 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296, 0636, 0650, 0651, 0652, 0653, 0654, 0655, 0657, 0658, 0662, 0663, 0665, 0672, 0673, 0675, 0676, 0682, 0683, 0685, 0686, 0692, 0693, 0695, 0696, 4469, 4470, 4471, 4472, 4473, 4474, 4479, 4480, 4542, 4543, 4544, 4591, 4592, 4593, 4603, 4671, 4672, 4674, 4675, 4677, 4678, 6100, 6220, 6221, 6402, 6403, 6773, 6996, 7145, 7148, 7735, 7736, 7740, 7741, 7742, 7840, 7841, 7842
Part Number: 359450-007
Safety Related Revision? No
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Vercise Gevia™ Information for Prescribers
Oct 17, 2019
Vercise Gevia™ DBS System
PDF( 350.0 KB )
Model(s): DB-1200-S
Part Number: 92152385-04
Safety Related Revision? No
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Vercise™ PC and Vercise Gevia™ Information for Patients
Oct 17, 2019
Vercise™ PC and Vercise Gevia™ DBS Systems
PDF( 1.0 MB )
Part Number: 92104394-03
Safety Related Revision? No
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AMS 700™ with MS Pump™ - Instructions for Use
Oct 01, 2019
Penile Prosthesis Product Line
PDF( 561.0 KB )
Model(s): 72401850, 72404010, 72404011, 72404012, 72404013, 72404014, 72404155, 72404156, 72404161, 72404162, 72404171, 72404172, 72404173, 72404174, 72404175, 72404209, 72404230, 72404231, 72404232, 72404233, 72404234, 72404235, 72404236, 72404237, 72404238, 72404239, 72404241, 72404242, 72404243, 72404244, 72404250, 72404251, 72404252, 72404253, 72404255, 72404256, 72404257, 72404258, 72404260, 72404261, 72404262, 72404263, 72404264, 72404265, 72404266, 72404267, 72404268, 72404269, 72404271, 72404272, 72404273, 72404274, 72404275, 72404280, 72404281, 72404282, 72404283, 72404284, 72404285, 72404286, 72404287, 72404288, 72404289, 72404291, 72404292, 72404293, 72404294, 72404300, 72404301, 72404302, 72404303, 72404305, 72404306, 72404307, 72404308, 72404310, 72404320, 72404321, 72404322, 72404323, 72404324, 72404325, 72404326, 72404330, 720182-01, 720185-01
Part Number: 92162915-01B
Safety Related Revision? No
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AMS 700™ with MS Pump™ - Operating Room Manual
Oct 01, 2019
Penile Prosthesis
PDF( 2.0 MB )
Model(s): 72401850, 72404010, 72404011, 72404012, 72404013, 72404014, 72404155, 72404156, 72404161, 72404162, 72404171, 72404172, 72404173, 72404174, 72404175, 72404209, 72404230, 72404231, 72404232, 72404233, 72404234, 72404235, 72404236, 72404237, 72404238, 72404239, 72404241, 72404242, 72404243, 72404244, 72404250, 72404251, 72404252, 72404253, 72404255, 72404256, 72404257, 72404258, 72404260, 72404261, 72404262, 72404263, 72404264, 72404265, 72404266, 72404267, 72404268, 72404269, 72404271, 72404272, 72404273, 72404274, 72404275, 72404280, 72404281, 72404282, 72404283, 72404284, 72404285, 72404286, 72404287, 72404288, 72404289, 72404291, 72404292, 72404293, 72404294, 72404300, 72404301, 72404302, 72404303, 72404305, 72404306, 72404307, 72404308, 72404310, 72404320, 72404321, 72404322, 72404323, 72404324, 72404325, 72404326, 72404330, 720182-01, 720185-01
Part Number: 92127382-01C
Safety Related Revision? No
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AMS™ Disposable Dilators - Instructions for Use
Oct 01, 2019
Disposable Dilator
PDF( 297.0 KB )
Model(s): 720131-01
Part Number: 92130122-01B
Safety Related Revision? No
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AMS™ Quick Connect - Instructions for Use
Oct 01, 2019
Sutureless Window Connectors
PDF( 205.0 KB )
Model(s): 72400023, 72400024, 72400025, 72400095, 72400098, 72400160, 72400161, 72400162, 72400163, 72400164, 72400165, 72400166, 72400167, 72400168, 72400170, 72400172, 72400174, 72401685, 72401850, 72404010, 72404011, 72404012, 72404013, 72404014, 72404127, 72404130, 72404131, 72404132, 72404133, 72404134, 72404135, 72404136, 72404137, 72404138, 72404140, 72404142, 72404144, 72404155, 72404156, 72404161, 72404162, 72404171, 72404172, 72404173, 72404174, 72404175, 72404209, 72404230, 72404231, 72404232, 72404233, 72404234, 72404235, 72404236, 72404237, 72404238, 72404239, 72404241, 72404242, 72404243, 72404244, 72404250, 72404251, 72404252, 72404253, 72404255, 72404256, 72404257, 72404258, 72404260, 72404261, 72404262, 72404263, 72404264, 72404265, 72404266, 72404267, 72404268, 72404269, 72404271, 72404272, 72404273, 72404274, 72404275, 72404280, 72404281, 72404282, 72404283, 72404284, 72404285, 72404286, 72404287, 72404288, 72404289, 72404291, 72404292, 72404293, 72404294, 72404300, 72404301, 72404302, 72404303, 72404305, 72404306, 72404307, 72404308, 72404310, 720133-01, 720157-01, 720182-01, 720185-01, 72404232-10, 72404233-12, 72404234-14, 72404252-10, 72404253-12, 72404282-10, 72404283-12, 72404284-14, 72404302-10, 72404303-12
Part Number: 230128-01D
Safety Related Revision? No
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CrossBoss™- Directions for Use
Oct 01, 2019
Catheter
PDF( 68.0 KB )
Model(s): NA
Part Number: 50943027-01A
Safety Related Revision? No
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myLUX™ Patient App for Insertable Cardiac Monitor
Oct 01, 2019
PDF( 15.0 MB )
Model(s): 2925
Part Number: 92216677-001
Safety Related Revision? No
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Quick Start Guide LUX-Dx™ Clinic Assistant App
Oct 01, 2019
PDF( 1.0 MB )
Model(s): 2935, M301
Part Number: 50942111-001
Safety Related Revision? No
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Quick Start Guide myLUX™ Patient App
Oct 01, 2019
PDF( 1.0 MB )
Model(s): 2935, M301
Part Number: 50942114-001
Safety Related Revision? No
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Rezum Delivery Device Kit for BPH Directions for Use
Oct 01, 2019
Rezum Delivery Device Kit for BPH
PDF( 1.0 MB )
Model(s): D2201-003
Part Number: 50998296-01A
Safety Related Revision? No
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SYNERGY™ XD- Patient Guide
Oct 01, 2019
Everolimus-Eluting Platinum Chromium Coronary Stent System
PDF( 104.0 KB )
Model(s): H7493941808220; H7493941808250; H7493941808270; H7493941808300; H7493941808350; H7493941808400; H7493941812220; H7493941812250; H7493941812270; H7493941812300; H7493941812350; H7493941812400; H7493941812450; H7493941812500; H7493941816220; H7493941816250; H7493941816270; H7493941816300; H7493941816350; H7493941816400; H7493941816450; H7493941816500; H7493941820220; H7493941820250; H7493941820270; H7493941820300; H7493941820350; H7493941820400; H7493941820450; H7493941820500; H7493941824220; H7493941824250; H7493941824270; H7493941824300; H7493941824350; H7493941824400; H7493941824450; H7493941824500; H7493941828220; H7493941828250; H7493941828270; H7493941828300; H7493941828350; H7493941828400; H7493941828450; H7493941828500; H7493941832220; H7493941832250; H7493941832270; H7493941832300; H7493941832350; H7493941832400; H7493941832450; H7493941832500; H7493941838220; H7493941838250; H7493941838270; H7493941838300; H7493941838350; H7493941838400; H7493941848250; H7493941848270; H7493941848300; H7493941848350; H7493941848400
Part Number: 50786168-02A
Safety Related Revision? No
-
WATCHMAN® Left Atrial Appendage Closure Device-Patient Information Guide
Oct 01, 2019
Left Atrial Appendage Closure Device
PDF( 273.0 KB )
Part Number: 50879598-02A
Safety Related Revision? No
-
Vercise™ DBS Labeling Symbols (Clinician)
Sep 23, 2019
Vercise™ PC and Vercise Gevia™ DBS Systems
PDF( 200.0 KB )
Part Number: 92104393-02
Safety Related Revision? No
-
Vercise™ DBS Physician Manual
Sep 23, 2019
Vercise™ DBS System
PDF( 3.0 MB )
Model(s): DB-1110-C DB-2201-30-DC DB-2201-45-DC DB-2201-30-AC DB-2201-45-BC NM-3138-55 DB-5110-C DB-5212-C DB-5500-1 DB-64125-US
Part Number: 92093580-03
Safety Related Revision? No
-
Vercise™ PC Information for Prescribers
Sep 23, 2019
Vercise™ PC DBS System
PDF( 378.0 KB )
Model(s): DB-1140-S
Part Number: 92104392-03
Safety Related Revision? No
-
ImageReady™ MRI Head Only Guidelines for Precision Spectra™ Spinal Cord Stimulator System
Sep 05, 2019
Precision Spectra™ Spinal Cord Stimulator System
PDF( 321.0 KB )
Model(s): SC-1132, SC-4401, SC-2158-30, SC-2158-50, SC-2218-30, SC-2218-50, SC-2352-50, SC-2366-50, SC-2317-50, SC-8216-50, SC-8416-50, SC-8336-50, SC-8352-50, SC-4316, SC-4318, SC-4320
Part Number: 91057049-04
Safety Related Revision? No
-
ImageReady™ MRI Head Only Guidelines for Spectra WaveWriter™ Spinal Cord Stimulator System
Sep 05, 2019
Spectra WaveWriter™ Spinal Cord Stimulator System
PDF( 336.0 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-2317-50, SC-8216-50, SC-8416-50, SC-8336-50, SC-8352-50, SC-4316, SC-4318, SC-4320
Part Number: 91171762-02
Safety Related Revision? No
-
ELUVIA™ - Directions for Use
Sep 01, 2019
Drug-Eluting Vascular Stent System
PDF( 286.0 KB )
Part Number: 50965773-01A
Safety Related Revision? No
-
Stingray™ - Directions for Use
Sep 01, 2019
Guidewire with Hydrophilic Coating
PDF( 69.0 KB )
Model(s): NA
Part Number: 50943030-01A
Safety Related Revision? No
-
ImageReady™ MRI Guidelines for Boston Scientific Deep Brain Stimulation Systems
Aug 20, 2019
Vercise™, Vercise™ PC and Vercise Gevia™ DBS Systems
PDF( 776.0 KB )
Model(s): DB-2201-30-DC, DB-2201-45-DC, DB-2202-30, DB-2202-45, DB-4600-C, NM-3138-55, DB-1200-S
Part Number: 92195369-01
Safety Related Revision? No
-
Bionic Navigator™ 3D System Programming Manual
Aug 06, 2019
PDF( 8.0 MB )
Model(s): "SC-7101-220 NM-7161 NM-7161-R NM-7161-102 NM-7161-102-R NM-7153-11A NM-7153-11AR NM-7153-30 NM-7153-30R"
Part Number: 92304128-01
Safety Related Revision? No
-
ELUVIA™ - Patient Information Guide
Aug 01, 2019
Drug-Eluting Vascular Stent System
PDF( 3.0 MB )
Part Number: 50965774-02A
Safety Related Revision? No
-
HEART CONNECT™ SYSTEM - INSTRUCTIONS FOR USE
Aug 01, 2019
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( 10.0 MB )
Model(s): 3120, 3933, 3934, 3935, 3936, 3937
Part Number: 359494-003
Safety Related Revision? No
-
LOTUS Edge™Valve System - Directions for Use
Aug 01, 2019
Transcatheter Aortic Valve Prosthesis Premounted on Delivery System
PDF( 310.0 KB )
Model(s): H749LVSUS230, H749LVSUS250, H749LVSUS270
Part Number: 52404402-01A
Safety Related Revision? No
-
MRI TECHNICAL GUIDE IMAGEREADY™ MR Conditional ICM System
Aug 01, 2019
PDF( 129.0 KB )
Model(s): M301
Part Number: 92216906-001
Safety Related Revision? No
-
rezum™ Generator - Programming and Operator's Manual
Aug 01, 2019
rezum™ Generator
PDF( 8.0 MB )
Model(s): G2200-003
Part Number: 50909085-01A
Safety Related Revision? No
-
Symphion™ Tissue Removal System- Directions for Use (Applicable to Software Version 2.0.19)
Aug 01, 2019
Tissue Removal System
PDF( 1.0 MB )
Part Number: 91061461-01D
Safety Related Revision? No
-
Reference Guide for Nate EN US
Jul 16, 2019
Reference Guide for SCS Systems
PDF( 200.0 KB )
Part Number: 91005942-06
Safety Related Revision? No
-
EMBLEM™ S-ICD - INSTRUCTIONS FOR USE
Jul 01, 2019
Automated Screening Tool (AST)
PDF( 534.0 KB )
Model(s): 3889
Part Number: 92383665-001
Safety Related Revision? No
-
MRI TECHNICAL GUIDE IMAGEREADY™ MR Conditional Pacing System
Jul 01, 2019
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, 7840, 7841, 7842
Part Number: 360167-003
Safety Related Revision? No
-
PHYSICIAN’S LEAD MANUAL INGEVITY™+
Jul 01, 2019
Pace/Sense Lead IS-1 Bipolar Connector Extendable/Retractable Fixation
PDF( 1.0 MB )
Model(s): 7840, 7841, 7842
Part Number: 92383113-001
-
Boston Scientific DBS Reference Guide
Jun 25, 2019
Vercise™, Vercise PC, and Vercise Gevia™ DBS Systems
PDF( 493.0 KB )
Part Number: 92094272-03
Safety Related Revision? No
-
Vercise™ DBS Charging System Quick Start Guide
Jun 25, 2019
Vercise™ and Vercise Gevia™ DBS Systems
PDF( 3.0 MB )
Model(s): DB-64125-US
Part Number: 92354415-01
Safety Related Revision? No
-
Vercise™ DBS Remote Control 3 Quick Start Guide
Jun 25, 2019
Vercise™ PC and Vercise Gevia™ DBS Systems
PDF( 3.0 MB )
Model(s): DB-5552-1, DB-5250-S
Part Number: 92354407-01
Safety Related Revision? No
-
Vercise™ DBS Remote Control Quick Start Guide
Jun 25, 2019
Vercise™ DBS System
PDF( 2.0 MB )
Model(s): DB-5550-1, DB-5212-C
Part Number: 92354396-01
Safety Related Revision? No
-
Vercise Neural Navigator 2.1 Quick Start Guide
Jun 17, 2019
Vercise™ PC and Vercise Gevia™ DBS Systems
PDF( 420.0 KB )
Model(s): DB-7105-N21
Part Number: 92290382-02
Safety Related Revision? No
-
Network and Connectivity - OPERATOR’S MANUAL
Jun 01, 2019
Application for use with the LATITUDE™ Programming System
PDF( 3.0 MB )
Model(s): 3924, 3300
Part Number: 360165-003
Safety Related Revision? No
-
Vercise Neural Navigator 3 Installation Guide
May 28, 2019
Vercise™ PC and Vercise Gevia™ DBS Systems
PDF( 794.0 KB )
Model(s): M365DB7105N310
Part Number: 92375868-01
Safety Related Revision? No
-
"Nevro Lead Compatitibility "
May 13, 2019
"Nevro Lead Compatitibility "
PDF( 583.0 KB )
Part Number: 91131569-01
Safety Related Revision? No
-
Koala™ - Directions for Use
May 01, 2019
Cleaning Sponge plus Pure™ Enzymatic
PDF( 42.0 KB )
Model(s): SES-240
Part Number: 50889519-01A
Safety Related Revision? No
-
Precision Novi™ System Information for Prescribers
Apr 15, 2019
Info for Prescribers Novi RC4 BLE US EN
PDF( 1.0 MB )
Part Number: 92304891-01
Safety Related Revision? No
-
Precision Spectra™ Spinal Cord Stimulator System
Apr 15, 2019
Info for Prescribers Spectra RC4 BLE US EN
PDF( 925.0 KB )
Part Number: 92304887-01
Safety Related Revision? No
-
Precision™ Montage™ MRI Spinal Cord Stimulator System
Apr 15, 2019
Info for Prescribers Montage MRI RC4 BLE US EN
PDF( 841.0 KB )
Part Number: 92304895-01
Safety Related Revision? No
-
Spectra WaveWriter™ Spinal Cord Stimulator System
Apr 15, 2019
Info for Prescribers Ninja RC4 BLE US EN
PDF( 927.0 KB )
Part Number: 92256650-01
Safety Related Revision? No
-
AUTOGEN™ CRT-D, AUTOGEN™ X4 CRT-D, DYNAGEN™ CRT-D, DYNAGEN™ X4 CRT-D, INOGEN™ CRT-D, INOGEN™ X4 CRT-D, ORIGEN™ CRT-D, ORIGEN™ X4 CRT-D, INCEPTA™ CRT-D, ENERGEN™ CRT-D, PUNCTUA™ CRT-D, COGNIS™ 100-D CRT-D - REFERENCE GUIDECARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
Apr 01, 2019
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
PDF( 10.0 MB )
Model(s): G050, G051, G056, G058, G140, G141, G146, G148, G150, G151, G154, G156, G158, G160, G161, G164, G166, G168, N050, N051, N118, N119, N140, N141, N160, N161, N164
Part Number: 359405-004
Safety Related Revision? No
-
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, 2019
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
PDF( 9.0 MB )
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, D160, D161, D162, D163, E050, E051, E052, E053, E102, E110, E140, E141, E142, E143, E160, E161, E162, E163
Part Number: 359407-004
Safety Related Revision? No
-
Freelink™ Remote Control
Apr 01, 2019
Clinician Manual Ninja RC4 BLE US EN
PDF( 2.0 MB )
Part Number: 92253735-01
Safety Related Revision? No
-
LATITUDE™ Heart Connect™ System - OPERATOR’S MANUAL
Apr 01, 2019
PDF( 3.0 MB )
Model(s): 3932, 3300, 3935, 3936, 3937
Part Number: 92302084-001
Safety Related Revision? No
-
LOTUS Edge™ Valve System - Patient and Caregiver Information Guide
Apr 01, 2019
Transcatheter Aortic Valve Prosthesis Premounted on Delivery System
PDF( 4.0 MB )
Part Number: 50806294-02A
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 - REFERENCE GUIDE
Apr 01, 2019
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
PDF( 12.0 MB )
Model(s): G124, G125, G126, G128, G138, G224, G225, G228, G237, G247, G248, G424, G425, G426, G428, G437, G447, G448, G524, G525, G526, G528, G537, G547, G548
Part Number: 360196-004
Safety Related Revision? No
-
RESONATE™ HF ICD, RESONATE™ EL ICD, PERCIVA™ HF ICD, PERCIVA™ ICD, VIGILANT™ EL ICD, MOMENTUM™ EL ICD - REFERENCE GUIDE
Apr 01, 2019
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
PDF( 10.0 MB )
Model(s): D120, D121, D220, D221, D232, D233, D400, D401, D412, D413, D420, D421, D432, D433, D500, D501, D512, D513, D520, D521, D532, D533
Part Number: 360197-004
Safety Related Revision? No
-
MADIT-RIT STUDY - CLINICAL SUMMARY
Mar 01, 2019
PDF( 197.0 KB )
Part Number: 92366120-001
Safety Related Revision? No
-
AngioJet™ Ultra 5000A Console - Operator's Manual
Feb 01, 2019
Thrombectomy System Console
PDF( 7.0 MB )
Model(s): 105650-001
Part Number: 50779353-01A
Safety Related Revision? No
-
Orca®/OrcaPod™ - Directions for Use
Feb 01, 2019
Single Use Air/Water, Suction, Valve Set; Single Use Air/Water, Suction, & Biopsy Valve Set with Water Jet Connector
PDF( 51.0 KB )
Model(s): SUV-617, SUV-618, SUV-628, SUV-629, SUV-632, SUV-633
Part Number: 50819578-01A
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
Feb 01, 2019
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
PDF( 814.0 KB )
Model(s): G124, G125, G126, G128, G138, G224, G225, G228, G237, G247, G248, G424, G425, G426, G428, G437, G447, G448, G524, G525, G526, G528, G537, G547, G548
Part Number: 360198-003
Safety Related Revision? No
-
RESONATE™ HF ICD, RESONATE™ EL ICD, PERCIVA™ HF ICD, PERCIVA™ ICD, VIGILANT™ EL ICD, MOMENTUM™ EL ICD - PHYSICIAN’S TECHNICAL MANUAL
Feb 01, 2019
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
PDF( 694.0 KB )
Model(s): D120, D121, D220, D221, D232, D233, D400, D401, D412, D413, D420, D421, D432, D433, D500, D501, D512, D513, D520, D521, D532, D533
Part Number: 360199-003
Safety Related Revision? No
-
IMAGEREADY™ MR CONDITIONAL S-ICD SYSTEM - MRI TECHNICAL GUIDE
Jan 01, 2019
Model A209 and A219 pulse generators and all models of Boston Scientific/Cameron Health subcutaneous electrodes
PDF( 3.0 MB )
Model(s): A209, A219
Part Number: 359474-002
Safety Related Revision? No
-
Pacing System Analyzer (PSA) - OPERATOR’S MANUAL
Jan 01, 2019
Application for use with the LATITUDE™ Programming System
PDF( 1.0 MB )
Model(s): 3300, 3922
Part Number: 360163-005
Safety Related Revision? No
-
Vercise DBS Programming Quick Start Guide, Vercise DBS Programming Quick Start Guide
Dec 06, 2018
Vercise DBS System
PDF( 3.0 MB )
Model(s): DB-7101-204, DB-7161
Part Number: 92290361-01
-
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
Dec 01, 2018
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
PDF( 956.0 KB )
Model(s): G050, G051, G056, G058, G140, G141, G146, G148, G150, G151 G154, G156, G158, G160, G161, G164, G166, G168, N050, N051, N118, N119, N140, N141, N160, N161, N164
Part Number: 359401-005
Safety Related Revision? No
-
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
Dec 01, 2018
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
PDF( 860.0 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, D160, D161, D162, D163, E050, E051, E052, E053, E102, E110, E140, E141, E142, E143, E160, E161, E162, E163
Part Number: 359403-005
Safety Related Revision? No
-
Vercise™ Neural Navigator™ 2.1 Programming Manual
Nov 06, 2018
Vercise™ PC and Vercise Gevia™ DBS Systems
PDF( 2.0 MB )
Model(s): DB-7105-N21
Part Number: 92104396-03
Safety Related Revision? No
-
Blox™ - Directions for Use
Oct 01, 2018
Endoscopic Bite Block with Elastic Cloth Strap
PDF( 50.0 KB )
Model(s): SBT-114, SBT-321, SBT-546
Part Number: 50736124-01A
Safety Related Revision? No
-
EMBLEM™ S-ICD Programmer - PROGRAMMER USER’S MANUAL
Oct 01, 2018
PDF( 3.0 MB )
Model(s): 3200
Part Number: 359464-003
Safety Related Revision? No
-
EMBLEM™ S-ICD, EMBLEM™ MRI S-ICD - USER’S MANUAL
Oct 01, 2018
SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
PDF( 6.0 MB )
Model(s): A209, A219
Part Number: 359480-004
Safety Related Revision? No
-
Endoglide+™ - Directions for Use
Oct 01, 2018
Sterile Bacteriostatic Lubricating Gel
PDF( 35.0 KB )
Model(s): SLT-394, SLT-395
Part Number: 50736123-01A
Safety Related Revision? No
-
HedgeHog® - Directions for Use
Oct 01, 2018
Cleaning Brushes
PDF( 42.0 KB )
Model(s): SBB-119, SBB-382, SBD-228, SBD-289, SBD-291, SBS-227
Part Number: 50736125-01A
Safety Related Revision? No
-
Hydra™ - Directions for Use
Oct 01, 2018
Disposable Auxiliary Water Jet Connector
PDF( 40.0 KB )
Model(s): SIT-361, SIT-470
Part Number: 50736127-01A
Safety Related Revision? No
-
Seal™ - Directions for Use
Oct 01, 2018
Single Use Biopsy Valve
PDF( 41.0 KB )
Model(s): SBC-501
Part Number: 50736126-01A
Safety Related Revision? No
-
Sterile Lubricating Jelly - Directions for Use, Sterile Lubricating Jelly - Directions for Use
Oct 01, 2018
Sterile Lubricating Jelly
PDF( 37.0 KB )
Part Number: 50736129-01A
-
Blazer™ Open-Irrigated - Directions for Use
Sep 01, 2018
Ablation Catheter
PDF( 266.0 KB )
Part Number: 50751560-01A
Safety Related Revision? No
-
IntellaNav™ Open-Irrigated - Directions for Use
Sep 01, 2018
Ablation Catheter
PDF( 265.0 KB )
Part Number: 50751572-01A
Safety Related Revision? No
-
IntellaTip MiFi™ Open-Irrigated - Directions for Use
Sep 01, 2018
Ablation Catheter
PDF( 266.0 KB )
Part Number: 50751579-01A
Safety Related Revision? No
-
Ultra ICE™ Plus - PI - Directions for Use
Sep 01, 2018
Peripheral Imaging Catheter
PDF( 178.0 KB )
Model(s): 2256-00, 2256-01
Part Number: 50754211-01A
Safety Related Revision? No
-
Innova™ Vascular - Understanding Peripheral Artery Disease - Patient Information Guide
Aug 01, 2018
Self-Expanding Stent System
PDF( 2.0 MB )
Part Number: 50731980-02A
Field Action Number: 92264630
Safety Related Revision? Yes
-
LONGITUDINAL SURVEILLANCE REGISTRY OF ACUITY™ SPIRAL LEAD - CLINICAL SUMMARY,
Aug 01, 2018
PDF( 251.0 KB )
Model(s): 4591, 4592, 4593
Part Number: 92269560-001
-
OptiCross™ 6 - Directions for Use
Aug 01, 2018
40 MHz Coronary Imaging Catheter
PDF( 212.0 KB )
Model(s): 1462-00, 1462-09, 1814-00, 1814-01
Part Number: 50726169-01A
Safety Related Revision? No
-
OptiCross™ HD and OptiCross™ 6 HD - Directions for Use
Aug 01, 2018
60 MHz Coronary Imaging Catheters
PDF( 213.0 KB )
Model(s): 1462-00, 1462-11, 1462-12, 186754-12
Part Number: 50726168-01A
Safety Related Revision? No
-
Vercis Gevia™ Implantable Pulse Generator DFU
Jul 25, 2018
Vercise Gevia™ DBS System
PDF( 971.0 KB )
Model(s): DB-1200-S, NM-3138-55
Part Number: 92152386-03
Safety Related Revision? No
-
Vercise PC Implantable Pulse Generator DFU
Jul 25, 2018
Vercise PC Implantable Pulse Generator DFU
PDF( 997.0 KB )
Model(s): DB-1140-S, NM-3138-55
Part Number: 92104390-01
Safety Related Revision? No
-
Vercise™ DBS Leads DFU
Jul 25, 2018
Vercise™ DBS Leads DFU
PDF( 819.0 KB )
Model(s): DB-2202-30, DB-2202-45, DB-2201-30-DC, DB-2201-45-DC, DB-5132-S
Part Number: 92104398-01
Safety Related Revision? No
-
Vercise™ Remote Control 3 DFU
Jul 25, 2018
Vercise™ PC and Vercise Gevia™ DBS Systems
PDF( 2.0 MB )
Model(s): DB-5552-1, DB-5250-S
Part Number: 92104389-02
Safety Related Revision? No
-
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
-
Vercise™ DBS Remote Control 3 Handbook
Jul 11, 2018
Vercise™ PC and Vercise Gevia™ DBS Systems
PDF( 5.0 MB )
Model(s): DB-5552-1, DB-5250-S
Part Number: 92104391-02
Safety Related Revision? No
-
Innova™ Vascular - Directions for Use
Jul 01, 2018
Self-Expanding Stent System
PDF( 244.0 KB )
Part Number: 50723219-01A
Field Action Number: 92264630
Safety Related Revision? Yes
-
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™ DBS Programming Wand DFU, Vercise™ DBS Programming Wand DFU
Jun 29, 2018
Vercise™ PC and Vercise Gevia™ DBS Systems
PDF( 197.0 KB )
Model(s): DB-7190
Part Number: 92104387-01
Safety Related Revision? No
-
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
-
HeartLogic™ Heart Failure Diagnostic Service - PHYSICIAN’S TECHNICAL GUIDE
May 01, 2018
PDF( 1.0 MB )
Model(s): 3300, 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: 360200-002
Safety Related Revision? No
-
INGEVITY™ MRI - PHYSICIAN’S LEAD MANUAL
May 01, 2018
Pace/Sense Lead; IS-1 Bipolar Connector; Extendable/Retractable Fixation
PDF( 1.0 MB )
Model(s): 7740, 7741, 7742
Part Number: 358658-009
Safety Related Revision? No
-
INGEVITY™ MRI - PHYSICIAN’S LEAD MANUAL
May 01, 2018
Pace/Sense Lead; IS-1 Bipolar Connector; Tined Fixation
PDF( 1.0 MB )
Model(s): 7731, 7732, 7735, 7736
Part Number: 358660-009
Safety Related Revision? No
-
Non-Sterile Tools - Reprocessing Instructions
May 01, 2018
Non-Sterile Tools
PDF( 186.0 KB )
Model(s): 35400010, 72100005, 72400155, 72400271, 720153-01
Part Number: 50654567-01A
Safety Related Revision? No
-
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
-
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
-
OptiCross™ 18 - Directions for Use
Feb 01, 2018
30 MHz Peripheral Imaging Catheter
PDF( 222.0 KB )
Model(s): 1462-00, 1462-05
Part Number: 50618231-01A
Safety Related Revision? No
-
OptiCross™ X - Directions for Use
Feb 01, 2018
40 MHz Coronary Imaging Catheter
PDF( 225.0 KB )
Model(s): 1462-00, 1462-07, 1813-00, 1813-01
Part Number: 50618233-01A
Safety Related Revision? No
-
Ultra ICE™ Plus - Directions for Use
Feb 01, 2018
9 MHz IntraCardiac Echo Catheter
PDF( 194.0 KB )
Model(s): 1816-00, 1816-03
Part Number: 50618232-01A
Safety Related Revision? No
-
BN 1.2 Programming Guide
Jan 12, 2018
PDF( 2.0 MB )
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™ 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
-
IntellaNav™ ST - Directions for Use
Jan 01, 2018
Ablation Catheter
PDF( 277.0 KB )
Part Number: 50476382-01B
-
OptiCross™ - Directions for Use
Jan 01, 2018
40 MHz Coronary Imaging Catheter
PDF( 239.0 KB )
Model(s): 1462-00, 1462-03
Part Number: 50618229-01A
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
-
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
-
Guide to Replacement of Cardiac Implantable Pulse Generators
Dec 01, 2017
PDF( 157.0 MB )
Model(s): N/A
Part Number: 358331-003
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
-
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
-
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
-
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
-
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
-
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
-
Stingray™ - Directions for Use
Jul 01, 2017
Extension Wire
PDF( 47.0 KB )
Part Number: 50526084-01A
Safety Related Revision? No
-
WATCHMAN® Access System - Directions for Use
Jun 01, 2017
Access Sheath with Dilator
PDF( 52.0 KB )
Part Number: 50517368-01A
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
-
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
-
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
-
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
-
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
-
S-ICD System Clinical Investigation
Feb 01, 2017
CLINICAL SUMMARY
PDF( 763.0 KB )
Part Number: 92061781-001
Safety Related Revision? No
-
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
-
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
-
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
-
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
-
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
-
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
-
LATITUDE® Communicator Important Information
Nov 01, 2015
PDF( 48.0 KB )
Model(s): 6280, 6290
Part Number: 358080-001
Safety Related Revision? No
-
Labeling Symbols
Oct 30, 2015
PDF( 565.0 KB )
Part Number: 91006762-01 REV C
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™ MR Conditional S-ICD System - Patient Guide for MRI Scans
Aug 01, 2015
PDF( 61.0 KB )
Part Number: 359477-001
-
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
-
NC Emerge® - Directions For Use
Jul 01, 2015
PTCA Dilatation Catheter
PDF( 77.0 KB )
Part Number: 91074307-01A
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
-
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
-
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
-
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
-
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
-
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
-
ENDOTAK RELIANCE™ ENDOTAK RELIANCE™ S - PHYSICIAN'S LEAD MANUAL
May 01, 2013
Steroid-Eluting Tined Endocardial Defibrillation Leads
PDF( 674.0 KB )
Model(s): 0147, 0148, 0128
Part Number: 355456-007
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
-
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
-
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® 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
-
SYNERGY™ Instructions for Use
Everolimus-Eluting Platinum Chromium Coronary Stent System
PDF( 325.0 KB )
Model(s): H7493926008220; H7493926008250; H7493926008270; H7493926008300; H7493926008350; H7493926008400; H7493926012220; H7493926012250; H7493926012270; H7493926012300; H7493926012350; H7493926012400; H7493926012450; H7493926012500; H7493926016220; H7493926016250; H7493926016270; H7493926016300; H7493926016350; H7493926016400; H7493926016450; H7493926016500; H7493926020220; H7493926020250; H7493926020270; H7493926020300; H7493926020350; H7493926020400; H7493926020450; H7493926020500; H7493926024220; H7493926024250; H7493926024270; H7493926024300; H7493926024350; H7493926024400; H7493926024450; H7493926024500; H7493926028220; H7493926028250; H7493926028270; H7493926028300; H7493926028350; H7493926028400; H7493926028450; H7493926028500; H7493926032220; H7493926032250; H7493926032270; H7493926032300; H7493926032350; H7493926032400; H7493926032450; H7493926032500; H7493926038220; H7493926038250; H7493926038270; H7493926038300; H7493926038350; H7493926038400 H7493926108220; H7493926108250; H7493926108270; H7493926108300; H7493926108350; H7493926108400; H7493926112220; H7493926112250; H7493926112270; H7493926112300; H7493926112350; H7493926112400; H7493926116220; H7493926116250; H7493926116270; H7493926116300; H7493926116350; H7493926116400; H7493926120220; H7493926120250; H7493926120270; H7493926120300; H7493926120350; H7493926120400; H7493926124220; H7493926124250; H7493926124270;H7493926124300; H7493926124350; H7493926124400; H7493926128220; H7493926128250; H7493926128270; H7493926128300; H7493926128350; H7493926128400; H7493926132220; H7493926132250; H7493926132270; H7493926132300; H7493926132350; H7493926132400; H7493926138220; H7493926138250; H7493926138270; H7493926138300; H7493926138350; H7493926138400
Part Number: 50984864-01A
Safety Related Revision? No
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SYNERGY™ Patient Guide
Everolimus-Eluting Platinum Chromium Coronary Stent System
PDF( 115.0 KB )
Model(s): H7493926008220; H7493926008250; H7493926008270; H7493926008300; H7493926008350; H7493926008400; H7493926012220; H7493926012250; H7493926012270; H7493926012300; H7493926012350; H7493926012400; H7493926012450; H7493926012500; H7493926016220; H7493926016250; H7493926016270; H7493926016300; H7493926016350; H7493926016400; H7493926016450; H7493926016500; H7493926020220; H7493926020250; H7493926020270; H7493926020300; H7493926020350; H7493926020400; H7493926020450; H7493926020500; H7493926024220; H7493926024250; H7493926024270; H7493926024300; H7493926024350; H7493926024400; H7493926024450; H7493926024500; H7493926028220; H7493926028250; H7493926028270; H7493926028300; H7493926028350; H7493926028400; H7493926028450; H7493926028500; H7493926032220; H7493926032250; H7493926032270; H7493926032300; H7493926032350; H7493926032400; H7493926032450; H7493926032500; H7493926038220; H7493926038250; H7493926038270; H7493926038300; H7493926038350; H7493926038400 H7493926108220; H7493926108250; H7493926108270; H7493926108300; H7493926108350; H7493926108400; H7493926112220; H7493926112250; H7493926112270; H7493926112300; H7493926112350; H7493926112400; H7493926116220; H7493926116250; H7493926116270; H7493926116300; H7493926116350; H7493926116400; H7493926120220; H7493926120250; H7493926120270; H7493926120300; H7493926120350; H7493926120400; H7493926124220; H7493926124250; H7493926124270;H7493926124300; H7493926124350; H7493926124400; H7493926128220; H7493926128250; H7493926128270; H7493926128300; H7493926128350; H7493926128400; H7493926132220; H7493926132250; H7493926132270; H7493926132300; H7493926132350; H7493926132400; H7493926138220; H7493926138250; H7493926138270; H7493926138300; H7493926138350; H7493926138400
Part Number: 51128867-02A
Safety Related Revision? No
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