PMA P230013S013

Device: Edwards EVOQUE Tricuspid Valve Replacement System
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S013
Product code: NPW
Decision date: 2025-10-31
Classification: Cardiovascular
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Approval order statement: Approval for a revision to the Instructions for Use to add the results of the Full Cohort of the TRISCEND II trial.

Current openFDA PMA Record#

Device: Edwards EVOQUE Tricuspid Valve Replacement System
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S013
Product code: NPW
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Decision date: 2025-10-31
Decision code: APPR
Date received: 2025-05-06
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a revision to the Instructions for Use to add the results of the Full Cohort of the TRISCEND II trial.