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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 Elite Mitral; Epic Elite Aortic; Epic Supra G3 valves
Generic Nameheart-valve, non-allograft tissue
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP040021
Supplement NumberS061
Date Received12/22/2025
Decision Date06/22/2026
Product Code LWR 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a next generation of the Epic family of tissue heart valves, collectively referred to as Epic Elite/G3. The changes to the Epic Elite/G3 valves include the addition of an expansion feature on the stent to facilitate future Valve-in-Valve (ViV) procedures, a change in stent material to an equivalent material from the same supplier, and minor marking and suture changes.
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