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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™ VR Leadless Pacemaker, Aveir™ DR Leadless Pacemaker
Generic NameLeadless pacemaker
Regulation Number870.3610
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP150035
Supplement NumberS021
Date Received12/17/2024
Decision Date01/16/2025
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, Lot A Interior - # 2 Rd. Km. 67.5, Santana Industrial Park, Arecibo, Puerto Rico 00612 USA for sterilization, final packaging and labeling activities, and final acceptance and distribution of the device
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