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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.
 
DevicePERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP860057
Supplement NumberS220
Date Received10/31/2024
Decision Date04/10/2025
Product Code DYE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
modifications to the Instructions for Use to reflect the 8-year findings of the Post-Approval Study (PAS) Report submitted for the long term follow-up of the PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis prospective cohort study
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