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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.
 
DeviceAvant HF, Avant HF, Gallant HF, Entrant HF, Quadra Assura MP, Quadra Assura, Unify Assura, Quartet, QuickFlex Micro
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP030054
Supplement NumberS434
Date Received04/22/2025
Decision Date05/22/2025
Product Code NIK 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
an alternate and additional supplier for the sterile barrier Tyvek lids used in Cardiac Rhythm Management (CRM) devices
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