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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 SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System
Generic Namepulmonary valve prosthesis percutaneously delivered
Applicant
Edwards Lifesciences, LLC
one edwards way
irvine, CA 92614
PMA NumberP200015
Supplement NumberS008
Date Received02/22/2021
Decision Date03/19/2021
Product Code NPV 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Add low ethylene oxide concentration sterilization process (Cycle 335) for sterilization of THV devices.
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