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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 (9850TDS)
Generic NamePercutaneously Delivered Prostheses and Tricuspid Valves
ApplicantEdwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP230013
Supplement NumberS023
Date Received01/15/2026
Decision Date02/12/2026
Product Code NPW 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a change in sub-tier supplier for a raw material used in tubing components of the EVOQUE Tricuspid Delivery System and the Commander Delivery System
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