PMA P230013S017

Device: Edwards EVOQUE tricuspid delivery system
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S017
Product code: NPW
Decision date: 2025-07-23
Classification: Cardiovascular
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Approval order statement: implementation of a new inspection/acceptance criterion and a specification update for the guidewire lumen over-mold assembly component of the EVOQUE Tricuspid Delivery System

Current openFDA PMA Record#

Device: Edwards EVOQUE tricuspid delivery system
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S017
Product code: NPW
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Decision date: 2025-07-23
Decision code: OK30
Date received: 2025-06-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementation of a new inspection/acceptance criterion and a specification update for the guidewire lumen over-mold assembly component of the EVOQUE Tricuspid Delivery System