PMA P150048

Device: TRIFORMIS RESILIA Tricuspid Valve, Model 11300T Available in sizes: 25, 27, 29, 31 and 33 mm
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S069
Product code: LWR
Decision date: 2026-05-26
Generic name: heart-valve, non-allograft tissue
Approval order statement: Approval for various design modifications to the TRIFORMIS RESILIA Tricuspid Valve sewing ring.

Current openFDA PMA Record#

Device: TRIFORMIS RESILIA Tricuspid Valve, Model 11300T Available in sizes: 25, 27, 29, 31 and 33 mm
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S094
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2026-05-26
Decision code: APPR
Date received: 2025-11-18
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for various design modifications to the TRIFORMIS RESILIA Tricuspid Valve sewing ring.