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PDF 

Protege™ Neurostimulation Systems

[PDF 0.12MB] (EN)

Protégé MRI™ IPG, 16 CH, Rechargeable, Protégé™ IPG, 16-Channel Rechargeable More
3771ANS, 3789ANS More
ARTEN100145317 - 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.

Protege™ Neurostimulation Systems

Products, 2 Total

  • Protégé MRI™ IPG, 16 CH, Rechargeable
  • Protégé™ IPG, 16-Channel Rechargeable
See All

Protege™ Neurostimulation Systems

Reorder/Model Numbers, 2 Total

  • 3771ANS
  • 3789ANS
See All

PDF 

Tendril MRI™ Model LPA1200M Pacing Leads User's Manual

[PDF 14.51MB] (EN)

LPA1200M/46 Tendril MRILead, LPA1200M/52 Tendril MRI Lead, LPA1200M/58 Tendril MRI Lead More
100048895, 100048215, 100048252 More
ARTEN600217977 - B
Effective Begin Date 1/14/2022
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.

Tendril MRI™ Model LPA1200M Pacing Leads User's Manual

Products, 3 Total

  • LPA1200M/46 Tendril MRILead
  • LPA1200M/52 Tendril MRI Lead
  • LPA1200M/58 Tendril MRI Lead
See All

Tendril MRI™ Model LPA1200M Pacing Leads User's Manual

Reorder/Model Numbers, 3 Total

  • 100048895
  • 100048215
  • 100048252
See All

PDF Tendril MRI LPA1200M Active Fixation Bipolar Steroid-Eluting Endocardial Pacing Lead Spec Sheet [PDF 0.04MB] (EN)

LPA1200M/46 Tendril MRILead, LPA1200M/52 Tendril MRI Lead, LPA1200M/58 Tendril MRI Lead More
100048895, 100048215, 100048252 More
40007863 - B
Effective Begin Date 1/31/2017
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.

Tendril MRI LPA1200M Active Fixation Bipolar Steroid-Eluting Endocardial Pacing Lead Spec Sheet

Products, 3 Total

  • LPA1200M/46 Tendril MRILead
  • LPA1200M/52 Tendril MRI Lead
  • LPA1200M/58 Tendril MRI Lead
See All

Tendril MRI LPA1200M Active Fixation Bipolar Steroid-Eluting Endocardial Pacing Lead Spec Sheet

Reorder/Model Numbers, 3 Total

  • 100048895
  • 100048215
  • 100048252
See All

PDF MultiPoint™ Pacing IDE Study Clinical Summary [PDF 2.44MB] (EN)

CDHFA600Q Neutrino NxTHF_ICD_JMRI_US, CDDRA300Q Entrant DR_ICD_UMRI_US, CDHFA300Q Entrant HF_ICD_OMRI_US, CDVRA600Q Neutrino NxTVR_ICD_JMRI_US, CDVRA800Q More
100170659, 100167380, 100167451, 100170626, 100168192, 100170675, 100167329, 100168215, 100167396, 100167384, 100168022, 100167398, 100167399, 1001680 More
ARTEN600131538 - 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.

MultiPoint™ Pacing IDE Study Clinical Summary

Products, 15 Total

  • CDHFA600Q Neutrino NxTHF_ICD_JMRI_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
  • 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
See All

MultiPoint™ Pacing IDE Study Clinical Summary

Reorder/Model Numbers, 15 Total

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

PDF 

Prodigy™ Neurostimulation Systems

[PDF 0.12MB] (EN)

Prodigy MRI™ IPG, 16 CH, Rechargeable, Prodigy™ IPG More
3772ANS, 3799ANS More
ARTEN100144564 - 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.

Prodigy™ Neurostimulation Systems

Products, 2 Total

  • Prodigy MRI™ IPG, 16 CH, Rechargeable
  • Prodigy™ IPG
See All

Prodigy™ Neurostimulation Systems

Reorder/Model Numbers, 2 Total

  • 3772ANS
  • 3799ANS
See All

PDF ASSERT Study Clinical Summary [PDF 0.1MB] (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
ARTEN600131156 - 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.

ASSERT 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

ASSERT 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 Accent MRI™ Pacemaker and Tendril MRI™ Lead Investigational Device Exemption Study Clinical Summary [PDF 0.65MB] (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
ARTEN600131096 - 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.

Accent MRI™ Pacemaker and Tendril MRI™ Lead Investigational Device Exemption 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

Accent MRI™ Pacemaker and Tendril MRI™ Lead Investigational Device Exemption 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 

Tachycardia Devices Merlin Patient Care System Merlin 2 Patient Care System Help Manual

[PDF 4.1MB] (EN)

CDDRA700Q Avant DR_ICD_UMRI_US, CDHFA700Q Avant HF_ICD_UMRI_US, CDVRA500Q Gallant VR_ICD_UMRI_US, CDDRA500Q Gallant DR_ICD_UMRI_US, CDHFA500Q Gallant HF_I More
100167384, 100167402, 100167398, 100167399, 100167339, 100167340, 100167380, 100167389, 100168192, 100168214, 100168215, 100167396, 100170626, 1001706 More
ARTEN600163117 - A
Effective Begin Date 2/10/2022
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.

Tachycardia Devices Merlin Patient Care System Merlin 2 Patient Care System Help Manual

Products, 19 Total

  • CDDRA700Q Avant DR_ICD_UMRI_US
  • CDHFA700Q Avant HF_ICD_UMRI_US
  • CDVRA500Q Gallant VR_ICD_UMRI_US
  • CDDRA500Q Gallant DR_ICD_UMRI_US
  • CDHFA500Q Gallant HF_ICD_UMRI_US
  • CDVRA300Q Entrant VR_ICD_UMRI_US
  • CDDRA300Q Entrant DR_ICD_UMRI_US
  • CDHFA300Q Entrant HF_ICD_UMRI_US
  • CDVRA800Q Neutrino NxTVR_ICD_JMRI_US
  • CDDRA800Q Neutrino NxTDR_ICD_JMRI_US
  • CDHFA800Q Neutrino NxTHF_ICD_JMRI_US
  • CDVRA700Q Avant VR_ICD_UMRI_US
  • CDVRA600Q Neutrino NxTVR_ICD_JMRI_US
  • CDDRA600Q Neutrino NxTDR_ICD_JMRI_US
  • CDHFA600Q Neutrino NxTHF_ICD_JMRI_US
  • Merlin SW Kit, 3330 v25.0.1 v1 US
  • Model 3650 Merlin PCS US, 3330-1.1 Softw
  • Software for Merlin 2.0
  • Merlin SW Kit MER3400 v1.1.1 US
See All

Tachycardia Devices Merlin Patient Care System Merlin 2 Patient Care System Help Manual

Reorder/Model Numbers, 19 Total

  • 100167384
  • 100167402
  • 100167398
  • 100167399
  • 100167339
  • 100167340
  • 100167380
  • 100167389
  • 100168192
  • 100168214
  • 100168215
  • 100167396
  • 100170626
  • 100170678
  • 100170676
  • 600129396
  • 60003650-101
  • MER3400
  • 600177636
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 

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
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