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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 and Epic Supra Tissue Heart Valves
Generic Nameheart-valve, non-allograft tissue
ApplicantAbbott Medical
177 County Road B. East
St. Paul, MN 55117
PMA NumberP040021
Supplement NumberS046
Date Received04/30/2021
Decision Date05/28/2021
Product Code LWR 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for labeling changes related to future valve-in-valve procedures.
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