PMA P230013S029

Device: Edwards EVOQUE Tricuspid Valve Replacement System
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S029
Product code: NPW
Decision date: 2026-10-19
Classification: Cardiovascular
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Approval order statement: Approval for updated specifications for the Coated Capsule to allow signs of delamination on the inner diameter of the proximal weld ring.

Current openFDA PMA Record#

Device: Edwards EVOQUE Tricuspid Valve Replacement System
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S029
Product code: NPW
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Decision date: 2026-10-19
Decision code: APPR
Date received: 2026-04-28
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for updated specifications for the Coated Capsule to allow signs of delamination on the inner diameter of the proximal weld ring.