PMA P230013S010

Device: Edwards EVOQUE Tricuspid Valve Replacement System
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S010
Product code: NPW
Decision date: 2025-02-11
Classification: Cardiovascular
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Approval order statement: Approval for a new model of the loading system (Model 9850LSB) that incorporates minor changes in design and materials and an update to the Instructions for Use to include the option of hospital staff to participate in valve loading

Current openFDA PMA Record#

Device: Edwards EVOQUE Tricuspid Valve Replacement System
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S010
Product code: NPW
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Decision date: 2025-02-11
Decision code: APPR
Date received: 2024-11-14
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a new model of the loading system (Model 9850LSB) that incorporates minor changes in design and materials and an update to the Instructions for Use to include the option of hospital staff to participate in valve loading