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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 NumberS019
Date Received04/04/2022
Decision Date04/08/2022
Product Code NPV 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Modification to the inspection method of the Alterra Delivery System inner shaft from use of a Keyence system to a laser micrometer.
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