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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 

AveirTM Link Module Instructions for Use

[PDF 0.89MB] (EN)

LSP112V Aveir VR_Pacer_IDEMRI_US, LSL02, FG, Aveir Link Module,US, IDE, 3650 Merlin PCS, US,with 3330 v6.6.1 SW, 5 LEAD ECG YOKE LABELMODELS 3625, 5 LEAD More
100173657, 600135977, 100002504, 100055011, 100054876 More
ARTEN600186861 - A
Effective Begin Date 3/7/2022
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 Link Module Instructions for Use

Products, 5 Total

  • LSP112V Aveir VR_Pacer_IDEMRI_US
  • LSL02, FG, Aveir Link Module,US, IDE
  • 3650 Merlin PCS, US,with 3330 v6.6.1 SW
  • 5 LEAD ECG YOKE LABELMODELS 3625
  • 5 LEAD ECG YOKE LABELMODEL 3626
See All

AveirTM Link Module Instructions for Use

Reorder/Model Numbers, 5 Total

  • 100173657
  • 600135977
  • 100002504
  • 100055011
  • 100054876
See All

PDF 

Pulse Generator and Cardiac Resynchronization Therapy Pulse Generator

User's Manual

[PDF 5.12MB] (EN)

PM1160 Endurity_Pacemaker_U_US, PM1240 Assurity_Pacemaker_U_US, PM1272 Assurity MRI_Pacemaker_U_US, PM2160 Endurity_Pacemaker_U_US, PM2240 Assurity_Pacema More
100069035, 100069046, 100108441, 100069053, 100069070, 100108427, 100080933, 100080935, 100132737, 100132707 More
ARTEN600226857 - 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, 10 Total

  • PM1160 Endurity_Pacemaker_U_US
  • PM1240 Assurity_Pacemaker_U_US
  • PM1272 Assurity MRI_Pacemaker_U_US
  • PM2160 Endurity_Pacemaker_U_US
  • PM2240 Assurity_Pacemaker_U_US
  • PM2272 Assurity MRI_Pacemaker_U_US
  • PM3222 Allure RF_Pacemaker_U_US
  • PM3242 Allure Quadra RF_Pacemaker_U_US
  • PM3542 Quadra Allure_Pacemaker_U_US
  • PM3562 Quadra Allure MP_Pace_JMRI_US
See All

Pulse Generator and Cardiac Resynchronization Therapy Pulse Generator

User's Manual

Reorder/Model Numbers, 10 Total

  • 100069035
  • 100069046
  • 100108441
  • 100069053
  • 100069070
  • 100108427
  • 100080933
  • 100080935
  • 100132737
  • 100132707
See All

PDF Performance of Chamber Onset and Far Field Morphology SVT Discriminators Clinical Summary [PDF 0.11MB] (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, 100170659, 1001682 More
ARTEN600131456 - 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.

Performance of Chamber Onset and Far Field Morphology SVT Discriminators 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
  • CDHFA600Q Neutrino NxTHF_ICD_JMRI_US
  • CDHFA800Q Neutrino NxTHF_ICD_JMRI_US
  • CDDRA800Q NeutrinoNxT DR_ICD_JMRI_US
See All

Performance of Chamber Onset and Far Field Morphology SVT Discriminators Clinical Summary

Reorder/Model Numbers, 15 Total

  • 100167396
  • 100167384
  • 100168022
  • 100167398
  • 100167399
  • 100168025
  • 100167340
  • 100167380
  • 100167451
  • 100170626
  • 100168192
  • 100170675
  • 100170659
  • 100168215
  • 100167329
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 Bradycardia and Tachycardia Devices Merlin Patient Care System Help Manual, US [PDF 15.01MB] (EN)

CD1215-36Q Current AccelVR ICD_O_US, CD1215-36,CURRENT ACCELVR RF US FGI 1.2, CD3369-40C QuadraAssura MP_ICD_U_US, CD3369-40Q QuadraAssura MP_ICD_UMRI_US More
100006769, 100010230, 100080478, 100080439, 60011664-707, 60011670-207, 60010739-407, 60010742-407, 100004041, 100004079, 100005695, 100006989, 600116 More
ARTEN600125236 - A
Effective Begin Date 7/13/2022
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.

Bradycardia and Tachycardia Devices Merlin Patient Care System Help Manual, US

Products, 114 Total

  • CD1215-36Q Current AccelVR ICD_O_US
  • CD1215-36,CURRENT ACCELVR RF US FGI 1.2
  • CD3369-40C QuadraAssura MP_ICD_U_US
  • CD3369-40Q QuadraAssura MP_ICD_UMRI_US
  • 1107-30 Current VRCAST HEADER-non RF
  • 1107-36 Current VRICD_U_US
  • 1207-30 Current VR RF(CAST HEADER-RF)
  • 1207-36 Current VR RFICD_O_US
  • CD1207-36Q Current VRUS FGI
  • CD1211-36Q CurrentPlusVR ICD_U_US
  • CD1211-36,CURRENT VR RFUS FGI 1.3.5 AIO
  • CD1215-30 Current VR RFICD
  • 2107-30, Current DR, FGI OUS-Extended
  • 2207-30 CURRENT RF DR ICD
  • CD2207-36Q Current DRUS FGI
  • 2207-36 Current DR ICD
  • 2107-36 Current DRICD_O_US
  • CD1275-36 Ellipse VRICD_U_US
  • CD1275-36Q Ellipse VRICD_U_US
  • CD1311-36 Ellipse VRICD_U_US
  • CD1311-36Q Ellipse VRICD_U_US
  • CD1411-36C EllipseVR_ICD_U_US
  • CD1411-36Q EllipseVR_ICD_U_US
  • CD1411-36 EllipseVR_ICD_U_US
  • CD1411-36QC EllipseVR_ICD_U_US
See All

Bradycardia and Tachycardia Devices Merlin Patient Care System Help Manual, US

Reorder/Model Numbers, 114 Total

  • 100006769
  • 100010230
  • 100080478
  • 100080439
  • 60011664-707
  • 60011670-207
  • 60010739-407
  • 60010742-407
  • 100004041
  • 100004079
  • 100005695
  • 100006989
  • 60011663-507
  • 50020238-001
  • 100004047
  • 50020239-001
  • 60011669-407
  • 100048353
  • 100048354
  • 100057802
  • 100057803
  • 100080232
  • 100080244
  • 100080271
  • 100080272
See All

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 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 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 

Avant, Neutrino NxT, Gallant, and Entrant CRTD, ICD User Manual

[PDF 5.1MB] (EN)

CDVRA700Q Avant VR_ICD_UMRI_PR, CDVRA800Q NeutrinoNxT VR_ICD_JMRI_PR, CDVRA600Q Neutrino NxTVR_ICD_JMRI_PR, CDVRA500Q Gallant VR_ICD_UMRI_PR, CDVRA300Q En More
100167336, 100167457, 100170598, 100167412, 100167461, 100167326, 100167443, 100170628, 100167408, 100167390, 100167337, 100167444, 100170670, 1001674 More
ARTEN600169877 - B
Effective Begin Date 10/11/2021
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.

Avant, Neutrino NxT, Gallant, and Entrant CRTD, ICD User Manual

Products, 15 Total

  • CDVRA700Q Avant VR_ICD_UMRI_PR
  • CDVRA800Q NeutrinoNxT VR_ICD_JMRI_PR
  • CDVRA600Q Neutrino NxTVR_ICD_JMRI_PR
  • CDVRA500Q Gallant VR_ICD_UMRI_PR
  • CDVRA300Q Entrant VR_ICD_UMRI_PR
  • CDDRA700Q Avant DR_ICD_BMRI_PR
  • CDDRA800Q NeutrinoNxT DR_ICD_JMRI_PR
  • CDDRA600Q Neutrino NxTDR_ICD_JMRI_PR
  • CDDRA500Q Gallant DR_ICD_BMRI_PR
  • CDDRA300Q Entrant DR_ICD_UMRI_PR
  • CDHFA700Q Avant HF_ICD_BMRI_PR
  • CDHFA800Q NeutrinoNxT HF_ICD_JMRI_PR
  • CDHFA600Q Neutrino NxTHF_ICD_JMRI_PR
  • CDHFA500Q Gallant HF_ICD_BMRI_PR
  • CDHFA300Q Entrant HF_ICD_UMRI_PR
See All

Avant, Neutrino NxT, Gallant, and Entrant CRTD, ICD User Manual

Reorder/Model Numbers, 15 Total

  • 100167336
  • 100167457
  • 100170598
  • 100167412
  • 100167461
  • 100167326
  • 100167443
  • 100170628
  • 100167408
  • 100167390
  • 100167337
  • 100167444
  • 100170670
  • 100167410
  • 100167414
See All

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