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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.
 
DeviceMITRIS RESILIA Mitral Valve
Generic Nameheart-valve, non-allograft tissue
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614-5688
PMA NumberP150048
Supplement NumberS047
Date Received08/03/2020
Decision Date03/16/2022
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 material and design modifications related to the wireform, sewing ring, valve holder and valve handle
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