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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAveir DR Leadless System
Generic NameLeadless pacemaker
Regulation Number870.3610
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91342
PMA NumberP150035
Supplement NumberS003
Date Received01/17/2023
Decision Date06/29/2023
Product Code PNJ 
Docket Number 23M-3561
Notice Date 09/07/2023
Advisory Committee Cardiovascular
Clinical TrialsNCT05252702
Supplement TypePanel Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the Aveir DR Leadless System, Aveir Leadless Pacemaker (Right Ventricular), Aveir Leadless Pacemaker (Right Atrial), Aveir Delivery Catheter, Aveir Link Module.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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