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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.
 
DeviceEpic™ Plus, Epic™ Plus Supra, Epic™ Max, Epic™ Elite, Epic™ Supra G3 Tissue Heart Valves
Generic Nameheart-valve, non-allograft tissue
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP040021
Supplement NumberS063
Date Received08/18/2026
Decision Date09/18/2026
Product Code LWR 
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  
removal of the destructive pinch inspection at receiving (applicable to Epic Elite and Epic Supra G3 only) and the addition of a new non-destructive stent pinch inspection as a 100% in-process control for all Epic valves
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