PMA P230013S019

Device: EVOQUE Tricuspid Valve Replacement System
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S019
Product code: NPW
Decision date: 2025-11-19
Classification: Cardiovascular
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Approval order statement: approval for a shelf-life extension from 1 year to 2 years for the EVOQUE Tricuspid Delivery System, and shelf-life extension from 2 years to 3 years for the EVOQUE Tricuspid Valve Sterile Barrier Packaging System.

Current openFDA PMA Record#

Device: EVOQUE Tricuspid Valve Replacement System
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S019
Product code: NPW
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Decision date: 2025-11-19
Decision code: APPR
Date received: 2025-08-21
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for a shelf-life extension from 1 year to 2 years for the EVOQUE Tricuspid Delivery System, and shelf-life extension from 2 years to 3 years for the EVOQUE Tricuspid Valve Sterile Barrier Packaging System.