PMA P230013S016

Device: Edwards EVOQUE Transcatheter Tricuspid Valve Replacement System
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S016
Product code: NPW
Decision date: 2025-08-13
Classification: Cardiovascular
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Approval order statement: approval to add the Edwards Singapore facility, located in Changi, Singapore, as a qualified manufacturing site for the EVOQUE valve component of the EVOQUE TTVR System

Current openFDA PMA Record#

Device: Edwards EVOQUE Transcatheter Tricuspid Valve Replacement System
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S016
Product code: NPW
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Decision date: 2025-08-13
Decision code: APPR
Date received: 2025-06-17
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval to add the Edwards Singapore facility, located in Changi, Singapore, as a qualified manufacturing site for the EVOQUE valve component of the EVOQUE TTVR System