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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.
 
DeviceSAPIEN M3 Transcatheter Mitral Valve Replacement System
Generic NameProsthesis, mitral valve, percutaneously delivered
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP250019
Supplement NumberS001
Date Received01/20/2026
Decision Date02/19/2026
Product Code NPU 
Advisory Committee Cardiovascular
Clinical TrialsNCT04153292
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the protocols for the post-approval studies, "Continued Follow-up of ENCIRCLE Premarket Cohort" and "Registry-Based Real-World Use Surveillance", submitted to comply with the conditions of approval outlined in the approval order for P250019.
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