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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 EVOQUE Tricuspid Valve Replacement System
Generic NamePercutaneously Delivered Prostheses and Tricuspid Valves
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP230013
Supplement NumberS013
Date Received05/06/2025
Decision Date10/31/2025
Product Code NPW 
Advisory Committee Cardiovascular
Clinical TrialsNCT04482062
Supplement TypeNormal 180 Day 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 a revision to the Instructions for Use to add the results of the Full Cohort of the TRISCEND II trial.
Post-Approval StudyShow Report Schedule and Study Progress
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