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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.
 
DeviceEVOQUE Tricuspid Valve Replacement System
Generic NamePercutaneously Delivered Prostheses and Tricuspid Valves
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP230013
Supplement NumberS019
Date Received08/21/2025
Decision Date11/19/2025
Product Code NPW 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
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 shelf-life extension from 1 year to 2 years for the EVOQUE Tricuspid Delivery System, and shelf-life extension from 2 years to 3 years for the EVOQUE Tricuspid Valve Sterile Barrier Packaging System.
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