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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™ Leadless System (Dual-Chamber)
Generic NameLeadless pacemaker
Regulation Number870.3610
ApplicantAbbott Medical
15900 Valley View Court
Sylamr, CA 91342
PMA NumberP150035
Supplement NumberS013
Date Received06/28/2024
Decision Date09/25/2024
Product Code PNJ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
approval for a new dual-chamber functional operating mode (AAI(R)+VVI) for the Aveir DR Leadless Pacing System
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