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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 NumberS010
Date Received11/14/2024
Decision Date02/11/2025
Product Code NPW 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a new model of the loading system (Model 9850LSB) that incorporates minor changes in design and materials and an update to the Instructions for Use to include the option of hospital staff to participate in valve loading
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