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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
Approval Order Statement  
Approval for material and design modifications related to the wireform, sewing ring, valve holder and valve handle
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