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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 Pulmonic Valve Delivery System
Generic NamePulmonary valve prosthesis percutaneously delivered
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP200015
Supplement NumberS068
Date Received08/01/2025
Decision Date01/28/2026
Product Code NPV 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the next generation SAPIEN 3 pulmonic delivery system (models 9631PL20, 9631PL23, 9631PL26, and 9631PL29) and various updates to the Magnetic Resonance (MR) Safety information in the device labeling.
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