PMA P230013S004

Device: Edwards EVOQUE Tricuspid Valve Replacement System
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S004
Product code: NPW
Decision date: 2024-10-03
Classification: Cardiovascular
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Approval order statement: Approval for (1) addition of the 56 mm valve size; (2) various minor material and manufacturing changes to all valve sizes, including changing the anchor padding material and laser-cutting of the cloth components; and (3) various design changes to the EVOQUE loading system (Model 9850LSA).

Current openFDA PMA Record#

Device: Edwards EVOQUE Tricuspid Valve Replacement System
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S004
Product code: NPW
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Decision date: 2024-10-03
Decision code: APPR
Date received: 2024-04-25
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for (1) addition of the 56 mm valve size; (2) various minor material and manufacturing changes to all valve sizes, including changing the anchor padding material and laser-cutting of the cloth components; and (3) various design changes to the EVOQUE loading system (Model 9850LSA).