PMA P230013S025

Device: Edwards EVOQUE Tricuspid Valve Replacement System
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S025
Product code: NPW
Decision date: 2026-04-10
Classification: Cardiovascular
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Approval order statement: Approval for a labeling update to add a warning against deploying the valve if the delivery system’s functionality is compromised.

Current openFDA PMA Record#

Device: Edwards EVOQUE Tricuspid Valve Replacement System
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S025
Product code: NPW
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Decision date: 2026-04-10
Decision code: APPR
Date received: 2026-03-11
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a labeling update to add a warning against deploying the valve if the delivery system’s functionality is compromised.