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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 Pacemaker
Generic NameLeadless pacemaker
Regulation Number870.3610
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP150035
Supplement NumberS031
Date Received08/14/2025
Decision Date09/05/2025
Product Code PNJ 
Advisory Committee Cardiovascular
Clinical TrialsNCT05935007
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 the revised protocol for the post-approval study (PAS) submitted to comply with the conditions of approval outlined in our approval order P910023/S468
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