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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 Pulmonary Valve System with Alterra Adaptive Prestent
Generic NamePulmonary valve prosthesis percutaneously delivered
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP200015
Supplement NumberS033
Date Received01/23/2023
Decision Date02/22/2023
Product Code NPV 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for various revisions to the Instructions for Use for the SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent to provide additional instruction on deployment of the prestent and extend the recapture limit from 50% to 65%.
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