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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DeviceEdwards EVOQUE Tricuspid Valve Replacement System
Generic NamePercutaneously Delivered Prostheses and Tricuspid Valves
ApplicantEdwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614
PMA NumberP230013
Date Received03/31/2023
Decision Date02/01/2024
Product Code NPW 
Docket Number 24M-0303
Notice Date 02/02/2024
Advisory Committee Cardiovascular
Clinical TrialsNCT04482062
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Edwards EVOQUE Tricuspid Valve Replacement System. The device is indicated for the improvement of health status in patients with symptomatic severe tricuspid regurgitation (TR) despite optimal medical therapy (OMT), in whom tricuspid valve replacement is deemed appropriate by a heart team.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002