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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.
 
DeviceCarpentier-Edwards PERIMOUNT Magna Ease Aortic Heart Valve
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP860057
Supplement NumberS197
Date Received12/26/2019
Decision Date06/23/2020
Product Code DYE 
Advisory Committee Cardiovascular
Clinical TrialsNCT01171625
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a labeling change for the Carpentier-Edwards PERIMOUNT® Magna Ease® Aortic Heart Valve, model 3300TFX, to update the Instructions for Use (IFU) reflecting data from the completed Post-Approval Study.
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