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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.
 
DeviceEdwards Alterra Adaptive Prestent System
Generic Namepulmonary valve prosthesis percutaneously delivered
ApplicantEdwards Lifesciences, LLC
one edwards way
irvine, CA 92614
PMA NumberP200015
Supplement NumberS020
Date Received04/25/2022
Decision Date08/08/2022
Product Code NPV 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a new e-beam sterilizer for the Alterra Adaptive Prestent System.
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