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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, ventricular (LSP112V, LSP202V); Aveir Delivery Catheter (LSCD111, LSCD201)
Generic NameLeadless pacemaker
Regulation Number870.3610
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP150035
Supplement NumberS036
Date Received01/20/2026
Decision Date04/03/2026
Product Code PNJ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a labeling expansion to update the labeling for the Aveir VR Leadless Pacemaker to include delivery of the device through the internal jugular vein.
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