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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 NumberS027
Date Received03/20/2026
Decision Date09/16/2026
Product Code NPW 
Advisory Committee Cardiovascular
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 various modifications to the Instructions for Use, including the addition of internal jugular venous access and revision of the sizing table.
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