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PDF 

Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Trial Clinical Summary

[PDF 0.55MB] (EN)

CDHFA600Q Neutrino NxTHF_ICD_JMRI_US, CDHFA800Q Neutrino NxTHF_ICD_JMRI_US, CDVRA700Q Avant VR_ICD_UMRI_US, CDDRA700Q Avant DR_ICD_UMRI_US, CDHFA700Q Avan More
100170659, 100168215, 100167396, 100167384, 100168022, 100167398, 100167399, 100168025, 100167340, 100167380, 100167451, 100170626, 100168192, 1001706 More
ARTEN600131537 - A
Effective Begin Date 9/4/2020
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Trial Clinical Summary

Products, 15 Total

  • CDHFA600Q Neutrino NxTHF_ICD_JMRI_US
  • CDHFA800Q Neutrino NxTHF_ICD_JMRI_US
  • CDVRA700Q Avant VR_ICD_UMRI_US
  • CDDRA700Q Avant DR_ICD_UMRI_US
  • CDHFA700Q Avant HF_ICD_BMRI_US
  • CDVRA500Q Gallant VR_ICD_UMRI_US
  • CDDRA500Q Gallant DR_ICD_UMRI_US
  • CDHFA500Q Gallant HF_ICD_BMRI_US
  • CDVRA300Q Entrant VR_ICD_UMRI_US
  • CDDRA300Q Entrant DR_ICD_UMRI_US
  • CDHFA300Q Entrant HF_ICD_OMRI_US
  • CDVRA600Q Neutrino NxTVR_ICD_JMRI_US
  • CDVRA800Q Neutrino NxTVR_ICD_JMRI_US
  • CDDRA600Q Neutrino NxTDR_ICD_JMRI_US
  • CDDRA800Q NeutrinoNxT DR_ICD_JMRI_US
See All

Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Trial Clinical Summary

Reorder/Model Numbers, 15 Total

  • 100170659
  • 100168215
  • 100167396
  • 100167384
  • 100168022
  • 100167398
  • 100167399
  • 100168025
  • 100167340
  • 100167380
  • 100167451
  • 100170626
  • 100168192
  • 100170675
  • 100167329
See All

PDF Aveir™ Leadless Pacemaker and Delivery Catheter Instructions for Use [PDF 7.48MB] (EN)

3650 Merlin PCS, US,with 3330 v7.1.1 SW, LSP112V Aveir VR_Pacer_IDEMRI_US, LSL02, FG, Aveir Link Module,US, IDE, Aveir VR Del Cath US, IFU Aveir Retrieval More
100014333, 100173657, 600135977, 600174096, 600174816, 600175936 More
ARTEN600175956 - C
Effective Begin Date 4/4/2022
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

Aveir™ Leadless Pacemaker and Delivery Catheter Instructions for Use

Products, 6 Total

  • 3650 Merlin PCS, US,with 3330 v7.1.1 SW
  • LSP112V Aveir VR_Pacer_IDEMRI_US
  • LSL02, FG, Aveir Link Module,US, IDE
  • Aveir VR Del Cath US
  • IFU Aveir Retrieval Catheter US
  • IFU Aveir Introducer DR IDE
See All

Aveir™ Leadless Pacemaker and Delivery Catheter Instructions for Use

Reorder/Model Numbers, 6 Total

  • 100014333
  • 100173657
  • 600135977
  • 600174096
  • 600174816
  • 600175936
See All

PDF 

Quartet™ 1457Q Left Ventricular Heart Lead IDE Clinical Summary

[PDF 0.27MB] (EN)

CDHFA600Q Neutrino NxTHF_ICD_JMRI_US, CDHFA800Q Neutrino NxTHF_ICD_JMRI_US, CDVRA700Q Avant VR_ICD_UMRI_US, CDDRA700Q Avant DR_ICD_UMRI_US, CDHFA700Q Avan More
100170659, 100168215, 100167396, 100167384, 100168022, 100167398, 100167399, 100168025, 100167340, 100167380, 100167451, 100170626, 100168192, 1001706 More
ARTEN600131716 - A
Effective Begin Date 9/4/2020
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

Quartet™ 1457Q Left Ventricular Heart Lead IDE Clinical Summary

Products, 15 Total

  • CDHFA600Q Neutrino NxTHF_ICD_JMRI_US
  • CDHFA800Q Neutrino NxTHF_ICD_JMRI_US
  • CDVRA700Q Avant VR_ICD_UMRI_US
  • CDDRA700Q Avant DR_ICD_UMRI_US
  • CDHFA700Q Avant HF_ICD_BMRI_US
  • CDVRA500Q Gallant VR_ICD_UMRI_US
  • CDDRA500Q Gallant DR_ICD_UMRI_US
  • CDHFA500Q Gallant HF_ICD_BMRI_US
  • CDVRA300Q Entrant VR_ICD_UMRI_US
  • CDDRA300Q Entrant DR_ICD_UMRI_US
  • CDHFA300Q Entrant HF_ICD_OMRI_US
  • CDVRA600Q Neutrino NxTVR_ICD_JMRI_US
  • CDVRA800Q Neutrino NxTVR_ICD_JMRI_US
  • CDDRA600Q Neutrino NxTDR_ICD_JMRI_US
  • CDDRA800Q NeutrinoNxT DR_ICD_JMRI_US
See All

Quartet™ 1457Q Left Ventricular Heart Lead IDE Clinical Summary

Reorder/Model Numbers, 15 Total

  • 100170659
  • 100168215
  • 100167396
  • 100167384
  • 100168022
  • 100167398
  • 100167399
  • 100168025
  • 100167340
  • 100167380
  • 100167451
  • 100170626
  • 100168192
  • 100170675
  • 100167329
See All

PDF Implantable Pulse Generator Clinician's Manual, Prodigy™ IPG, Prodigy MRI™ IPG [PDF 1.39MB] (EN)

Prodigy MRI™ IPG, 16 CH, Rechargeable, Prodigy™ IPG, Eon® Port Plug, Tunneling Tool, 12", Torque Wrench More
3772ANS, 3799ANS, 1111ANS, 1112ANS, 1101ANS More
ARTEN100144509 - A
Effective Begin Date 11/7/2016
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

Implantable Pulse Generator Clinician's Manual, Prodigy™ IPG, Prodigy MRI™ IPG

Products, 5 Total

  • Prodigy MRI™ IPG, 16 CH, Rechargeable
  • Prodigy™ IPG
  • Eon® Port Plug
  • Tunneling Tool, 12"
  • Torque Wrench
See All

Implantable Pulse Generator Clinician's Manual, Prodigy™ IPG, Prodigy MRI™ IPG

Reorder/Model Numbers, 5 Total

  • 3772ANS
  • 3799ANS
  • 1111ANS
  • 1112ANS
  • 1101ANS
See All

PDF 

Pulse Generator and Cardiac Resynchronization Therapy Pulse Generator

User's Manual

[PDF 2.06MB] (EN)

PM1110 ACCENT SRPACEMAKER, PM1172 Endurity MRI_Pacemaker_U_US, PM1210 Accent SR RFPacemaker_U_US, PM1260 Assurity +_Pacemaker_U_US, PM2110 ACCENT DRPacema More
100015765, 100108432, 100034296, 100069036, 100034253, 100108355, 100069037, 60018905, 100069127, 100080947, 60019098, 100090392, 100090393, PM2210, 1 More
ARTEN600249097 - A
Effective Begin Date 3/4/2022
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

Pulse Generator and Cardiac Resynchronization Therapy Pulse Generator

User's Manual

Products, 16 Total

  • PM1110 ACCENT SRPACEMAKER
  • PM1172 Endurity MRI_Pacemaker_U_US
  • PM1210 Accent SR RFPacemaker_U_US
  • PM1260 Assurity +_Pacemaker_U_US
  • PM2110 ACCENT DRPacemaker_U_US
  • PM2172 Endurity MRI_Pacemaker_U_US
  • PM2260 Assurity +_Pacemaker_U_US
  • PM3110 AnthemPacemaker_U_US
  • PM3120 Allure_Pacemaker_U_US
  • PM3140 Allure Quadra_Pacemaker_U_US
  • PM3210 Anthem RFPacemaker_U_US
  • PM3160 Quadra Allure MP_Pacemaker_U_US
  • PM3262 Quadra Allure MPRF_Pacemake_U_US
  • PM2210 Accent DR RF pacemaker (US Model)
  • PM1224 Accent MRIPacemaker_B_US
  • PM2218 Accent MRIDR RF Pacemaker_U_US
See All

Pulse Generator and Cardiac Resynchronization Therapy Pulse Generator

User's Manual

Reorder/Model Numbers, 16 Total

  • 100015765
  • 100108432
  • 100034296
  • 100069036
  • 100034253
  • 100108355
  • 100069037
  • 60018905
  • 100069127
  • 100080947
  • 60019098
  • 100090392
  • 100090393
  • PM2210
  • 100027906
  • 100128344
See All

PDF SJM MRI Activator Handheld Device Model EX4000 User's Manual [PDF 0.34MB] (EN)

EX4000 MRI ActivatorAccessory_U_US More
100030064 More
60065403 - B
Effective Begin Date 2/9/2017
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

SJM MRI Activator Handheld Device Model EX4000 User's Manual

Products, 1 Total

  • EX4000 MRI ActivatorAccessory_U_US
See All

SJM MRI Activator Handheld Device Model EX4000 User's Manual

Reorder/Model Numbers, 1 Total

  • 100030064
See All

PDF AF Suppression™ Algorithm/CRT-D Study Clinical Summary [PDF 1MB] (EN)

CDVRA700Q Avant VR_ICD_UMRI_US, CDDRA700Q Avant DR_ICD_UMRI_US, CDHFA700Q Avant HF_ICD_BMRI_US, CDVRA500Q Gallant VR_ICD_UMRI_US, CDDRA500Q Gallant DR_ICD More
100167396, 100167384, 100168022, 100167398, 100167399, 100168025, 100167340, 100167380, 100167451, 100170626, 100168192, 100170675, 100167329, 1001706 More
ARTEN600131136 - A
Effective Begin Date 9/4/2020
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

AF Suppression™ Algorithm/CRT-D Study Clinical Summary

Products, 15 Total

  • CDVRA700Q Avant VR_ICD_UMRI_US
  • CDDRA700Q Avant DR_ICD_UMRI_US
  • CDHFA700Q Avant HF_ICD_BMRI_US
  • CDVRA500Q Gallant VR_ICD_UMRI_US
  • CDDRA500Q Gallant DR_ICD_UMRI_US
  • CDHFA500Q Gallant HF_ICD_BMRI_US
  • CDVRA300Q Entrant VR_ICD_UMRI_US
  • CDDRA300Q Entrant DR_ICD_UMRI_US
  • CDHFA300Q Entrant HF_ICD_OMRI_US
  • CDVRA600Q Neutrino NxTVR_ICD_JMRI_US
  • CDVRA800Q Neutrino NxTVR_ICD_JMRI_US
  • CDDRA600Q Neutrino NxTDR_ICD_JMRI_US
  • CDDRA800Q NeutrinoNxT DR_ICD_JMRI_US
  • CDHFA600Q Neutrino NxTHF_ICD_JMRI_US
  • CDHFA800Q Neutrino NxTHF_ICD_JMRI_US
See All

AF Suppression™ Algorithm/CRT-D Study Clinical Summary

Reorder/Model Numbers, 15 Total

  • 100167396
  • 100167384
  • 100168022
  • 100167398
  • 100167399
  • 100168025
  • 100167340
  • 100167380
  • 100167451
  • 100170626
  • 100168192
  • 100170675
  • 100167329
  • 100170659
  • 100168215
See All

PDF 

AveirTM Leadless Pacemaker Patient Manual

[PDF 6.42MB] (EN)

LSP112V Aveir VR_Pacer_IDEMRI_US, Aveir VR Del Cath US, LSL02, FG, Aveir Link Module,US, IDE, IFU Aveir Introducer DR IDE, 3650 Merlin PCS, US,with 3330 v More
100173657, 600174096, 600135977, 600175936, 100014333, 600174816 More
ARTEN600186857 - B
Effective Begin Date 3/23/2022
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

AveirTM Leadless Pacemaker Patient Manual

Products, 6 Total

  • LSP112V Aveir VR_Pacer_IDEMRI_US
  • Aveir VR Del Cath US
  • LSL02, FG, Aveir Link Module,US, IDE
  • IFU Aveir Introducer DR IDE
  • 3650 Merlin PCS, US,with 3330 v7.1.1 SW
  • IFU Aveir Retrieval Catheter US
See All

AveirTM Leadless Pacemaker Patient Manual

Reorder/Model Numbers, 6 Total

  • 100173657
  • 600174096
  • 600135977
  • 600175936
  • 100014333
  • 600174816
See All

PDF Rhythm ICD Study: V-V Optimization Phase Clinical Summary [PDF 0.17MB] (EN)

CDHFA700Q Avant HF_ICD_BMRI_US, CDVRA500Q Gallant VR_ICD_UMRI_US, CDDRA500Q Gallant DR_ICD_UMRI_US, CDHFA500Q Gallant HF_ICD_BMRI_US, CDVRA300Q Entrant VR More
100168022, 100167398, 100167399, 100168025, 100167340, 100167380, 100167451, 100170626, 100168192, 100170675, 100167329, 100170659, 100168215, 1001673 More
ARTEN600133776 - A
Effective Begin Date 9/4/2020
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

Rhythm ICD Study: V-V Optimization Phase Clinical Summary

Products, 15 Total

  • CDHFA700Q Avant HF_ICD_BMRI_US
  • CDVRA500Q Gallant VR_ICD_UMRI_US
  • CDDRA500Q Gallant DR_ICD_UMRI_US
  • CDHFA500Q Gallant HF_ICD_BMRI_US
  • CDVRA300Q Entrant VR_ICD_UMRI_US
  • CDDRA300Q Entrant DR_ICD_UMRI_US
  • CDHFA300Q Entrant HF_ICD_OMRI_US
  • CDVRA600Q Neutrino NxTVR_ICD_JMRI_US
  • CDVRA800Q Neutrino NxTVR_ICD_JMRI_US
  • CDDRA600Q Neutrino NxTDR_ICD_JMRI_US
  • CDDRA800Q NeutrinoNxT DR_ICD_JMRI_US
  • CDHFA600Q Neutrino NxTHF_ICD_JMRI_US
  • CDHFA800Q Neutrino NxTHF_ICD_JMRI_US
  • CDVRA700Q Avant VR_ICD_UMRI_US
  • CDDRA700Q Avant DR_ICD_UMRI_US
See All

Rhythm ICD Study: V-V Optimization Phase Clinical Summary

Reorder/Model Numbers, 15 Total

  • 100168022
  • 100167398
  • 100167399
  • 100168025
  • 100167340
  • 100167380
  • 100167451
  • 100170626
  • 100168192
  • 100170675
  • 100167329
  • 100170659
  • 100168215
  • 100167396
  • 100167384
See All

PDF Proclaim™ Implantable Pulse Generator Clinician's Manual, Models 3660, 3661, 3662, 3663, 3665, 3667 [PDF 0.6MB] (EN)

IPG, 5.3Ah, SCS, SJM Tonic, No MRI, IPG, 7.5Ah, SCS, SJM Tonic, No MRI, IPG, 5.3Ah, SCS, 1.27mm, IPG, 7.5Ah, SCS, 1.27mm, Eon® Port Plug, Torque Wrench, IPG More
3665ANS, 3667ANS, 3661ANS, 3663ANS, 1111ANS, 1101ANS, 3660ANS, 3662ANS More
ARTEN600144297 - B
Effective Begin Date 3/22/2021
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

Proclaim™ Implantable Pulse Generator Clinician's Manual, Models 3660, 3661, 3662, 3663, 3665, 3667

Products, 8 Total

  • IPG, 5.3Ah, SCS, SJM Tonic, No MRI
  • IPG, 7.5Ah, SCS, SJM Tonic, No MRI
  • IPG, 5.3Ah, SCS, 1.27mm
  • IPG, 7.5Ah, SCS, 1.27mm
  • Eon® Port Plug
  • Torque Wrench
  • IPG, 5.3Ah, SCS, SJM
  • IPG, 7.5Ah, SCS, SJM
See All

Proclaim™ Implantable Pulse Generator Clinician's Manual, Models 3660, 3661, 3662, 3663, 3665, 3667

Reorder/Model Numbers, 8 Total

  • 3665ANS
  • 3667ANS
  • 3661ANS
  • 3663ANS
  • 1111ANS
  • 1101ANS
  • 3660ANS
  • 3662ANS
See All
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