PMA P230013

Device: EVOQUE Tricuspid Valve Replacement System
Applicant: Edwards Lifesciences, LLC
Product code: NPW
Decision date: 2026-09-16
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Approval order statement: Approval for various modifications to the Instructions for Use, including the addition of internal jugular venous access and revision of the sizing table.

Current openFDA PMA Record#

Device: EVOQUE Tricuspid Valve Replacement System
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S027
Product code: NPW
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Decision date: 2026-09-16
Decision code: APPR
Date received: 2026-03-20
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for various modifications to the Instructions for Use, including the addition of internal jugular venous access and revision of the sizing table.