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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™ AR 2 LSP203A Leadless Pacemaker (LP) (atrial)
Generic NameLeadless pacemaker
Regulation Number870.3610
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP150035
Supplement NumberS029
Date Received07/16/2025
Decision Date08/15/2025
Product Code PNJ 
Advisory Committee Cardiovascular
Clinical TrialsNCT05252702
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval of version E of the protocol for the post-approval study (PAS) referenced above
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