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PDF Leadless II - Phase 2 Study, Summary of Clinical Results and Adverse Events [PDF 1.47MB] (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
ARTEN600259140 - B
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.

Leadless II - Phase 2 Study, Summary of Clinical Results and Adverse Events

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

Leadless II - Phase 2 Study, Summary of Clinical Results and Adverse Events

Reorder/Model Numbers, 6 Total

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

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 

AveirTM Leadless Pacemaker Help Manual

[PDF 0.63MB] (EN)

LSP112V Aveir VR_Pacer_IDEMRI_US, 3650 Merlin PCS, US,with 3330 v7.1.1 SW, Model LSL02, FG, AveriLink Module, US More
100173657, 100014333, 100171720 More
ARTEN600186859 - A
Effective Begin Date 2/28/2022
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 Help Manual

Products, 3 Total

  • LSP112V Aveir VR_Pacer_IDEMRI_US
  • 3650 Merlin PCS, US,with 3330 v7.1.1 SW
  • Model LSL02, FG, AveriLink Module, US
See All

AveirTM Leadless Pacemaker Help Manual

Reorder/Model Numbers, 3 Total

  • 100173657
  • 100014333
  • 100171720
See All

PDF 

Promote™ Q CRT-D and Quartet™ Left Ventricular Heart Lead Study

[PDF 1.83MB] (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
ARTEN600131636 - 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.

Promote™ Q CRT-D and Quartet™ Left Ventricular Heart Lead Study

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

Promote™ Q CRT-D and Quartet™ Left Ventricular Heart Lead Study

Reorder/Model Numbers, 15 Total

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