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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 Delivery Catheter (LSCD201)
Generic NameLeadless pacemaker
Regulation Number870.3610
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP150035
Supplement NumberS034
Date Received11/20/2025
Decision Date02/23/2026
Product Code PNJ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a manufacturing site located at Abbott Medical, Interior Lot A Road #2 Km 67.5 Santana Industrial Park Arecibo, Puerto Rico 00612 FEI: 3006705815 for manufacturing, packaging and EO sterilization.
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