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Results shown for product or part number 'Aveir':

9 Result(s)

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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 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 

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 Aveir™ Leadless Pacemaker and Delivery Catheter Instructions for Use [PDF 7.49MB] (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 - D
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 Aveir DR LP/DC US PMA IFU [PDF 10.23MB] (EN)

Leadless DR PM 19.5F 32.2MM RA, Leadless DR PM 19.5F 38.0MM RV, Aveir Leadless DR Del Cath More
LSP201A, LSP202V, LSCD201 More
ARTEN600284235 - A
Effective Begin Date 7/17/2023
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 DR LP/DC US PMA IFU

Products, 3 Total

  • Leadless DR PM 19.5F 32.2MM RA
  • Leadless DR PM 19.5F 38.0MM RV
  • Aveir Leadless DR Del Cath
See All

Aveir DR LP/DC US PMA IFU

Reorder/Model Numbers, 3 Total

  • LSP201A
  • LSP202V
  • LSCD201
See All

PDF IFU Clinical Summary AveirDR US [PDF 3.17MB] (EN)

3650 Merlin PCS, US,with 3330 v7.1.1 SW, Leadless DR PM 19.5F 32.2MM RA, Leadless DR PM 19.5F 38.0MM RV, LSL02, FG, Aveir Link Module,US, IDE, Aveir VR De More
100014333, LSP201A, LSP202V, 600135977, 600174096, 600174816, 600175936 More
ARTEN600284318 - C
Effective Begin Date 7/17/2023
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.

IFU Clinical Summary AveirDR US

Products, 7 Total

  • 3650 Merlin PCS, US,with 3330 v7.1.1 SW
  • Leadless DR PM 19.5F 32.2MM RA
  • Leadless DR PM 19.5F 38.0MM RV
  • LSL02, FG, Aveir Link Module,US, IDE
  • Aveir VR Del Cath US
  • IFU Aveir Retrieval Catheter US
  • IFU Aveir Introducer DR IDE
See All

IFU Clinical Summary AveirDR US

Reorder/Model Numbers, 7 Total

  • 100014333
  • LSP201A
  • LSP202V
  • 600135977
  • 600174096
  • 600174816
  • 600175936
See All

PDF IFU Aveir DR LP Brady Help US [PDF 8.97MB] (EN)

Leadless DR PM 19.5F 32.2MM RA, Leadless DR PM 19.5F 38.0MM RV, 3650 Merlin PCS, US,with 3330 v7.1.1 SW, Model LSL02, FG, AveriLink Module, US, LSP112V Av More
LSP201A, LSP202V, 100014333, 100171720, 100173657 More
ARTEN600282406 - A
Effective Begin Date 7/17/2023
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.

IFU Aveir DR LP Brady Help US

Products, 5 Total

  • Leadless DR PM 19.5F 32.2MM RA
  • Leadless DR PM 19.5F 38.0MM RV
  • 3650 Merlin PCS, US,with 3330 v7.1.1 SW
  • Model LSL02, FG, AveriLink Module, US
  • LSP112V Aveir VR_Pacer_IDEMRI_US
See All

IFU Aveir DR LP Brady Help US

Reorder/Model Numbers, 5 Total

  • LSP201A
  • LSP202V
  • 100014333
  • 100171720
  • 100173657
See All

PDF 

Aveir DR Link Module US PMA

[PDF 0.91MB] (EN)

AVEIR LINK MODULE VR/DR, LEADLESS VR PM 19.5F 38.5MM RV, Leadless DR PM 19.5F 32.2MM RA, Leadless DR PM 19.5F 38.0MM RV, Model 3625 ECG Cable US Tyco Ergo More
LSL02, LSP112V, LSP201A, LSP202V, 3625, 3626, 3650 More
ARTEN600302847 - A
Effective Begin Date 7/17/2023
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 DR Link Module US PMA

Products, 7 Total

  • AVEIR LINK MODULE VR/DR
  • LEADLESS VR PM 19.5F 38.5MM RV
  • Leadless DR PM 19.5F 32.2MM RA
  • Leadless DR PM 19.5F 38.0MM RV
  • Model 3625 ECG Cable US Tyco Ergoline, N
  • Model 3626 ECG Cable OUS Tyco Ergoline,
  • MODEL 3650 FGI, NGP
See All

Aveir DR Link Module US PMA

Reorder/Model Numbers, 7 Total

  • LSL02
  • LSP112V
  • LSP201A
  • LSP202V
  • 3625
  • 3626
  • 3650
See All

PDF 

AveirTM MRI-Ready Leadless System Manual

[PDF 3.84MB] (EN)

LSP112V Aveir VR_Pacer_IDEMRI_US, Leadless DR PM 19.5F 38.0MM RV, Leadless DR PM 19.5F 32.2MM RA More
100173657, LSP202V, LSP201A More
ARTEN600283064 - A
Effective Begin Date 7/17/2023
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 MRI-Ready Leadless System Manual

Products, 3 Total

  • LSP112V Aveir VR_Pacer_IDEMRI_US
  • Leadless DR PM 19.5F 38.0MM RV
  • Leadless DR PM 19.5F 32.2MM RA
See All

AveirTM MRI-Ready Leadless System Manual

Reorder/Model Numbers, 3 Total

  • 100173657
  • LSP202V
  • LSP201A
See All
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