PMA P150048S092

Device: TRIFORMIS RESILIA Tricuspid Valve
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S092
Product code: LWR
Decision date: 2025-10-27
Classification: Cardiovascular
Generic name: heart-valve, non-allograft tissue
Approval order statement: Approval for the MITRIS RESILIA Mitral Valve for expanding the indications to include the tricuspid position. The device, as modified, will be marketed under the trade name “TRIFORMIS RESILIA Tricuspid Valve” and is indicated for the replacement of native or prosthetic tricuspid heart valves.

Current openFDA PMA Record#

Device: TRIFORMIS RESILIA Tricuspid Valve
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S092
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2025-10-27
Decision code: APPR
Date received: 2025-04-30
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the MITRIS RESILIA Mitral Valve for expanding the indications to include the tricuspid position. The device, as modified, will be marketed under the trade name “TRIFORMIS RESILIA Tricuspid Valve” and is indicated for the replacement of native or prosthetic tricuspid heart valves.