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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DeviceAveir VR Leadless System
Generic NameLeadless pacemaker
Regulation Number870.3610
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91342
PMA NumberP150035
Date Received10/06/2015
Decision Date03/31/2022
Product Code PNJ 
Docket Number 22M-0502
Notice Date 04/01/2022
Advisory Committee Cardiovascular
Clinical TrialsNCT01700244
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
Approval for the Aveir Leadless Pacemaker, Aveir Delivery System Catheter, and Aveir Link Module.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S008 S009 S010 S011