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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™ Leadless Pacemaker (Right Ventricular), Aveir™ DR Leadless Pacemaker: Aveir™ Leadle
Generic NameLeadless pacemaker
Regulation Number870.3610
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91342
PMA NumberP150035
Supplement NumberS008
Date Received03/01/2024
Decision Date03/29/2024
Product Code PNJ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
use of automated equipment for the suture thermoforming and cutting manufacturing process
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