PMA P150048S097

Device: TRIFORMIS RESILIA Tricuspid Valve, Model 11300T
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S097
Product code: LWR
Decision date: 2026-02-06
Classification: Cardiovascular
Generic name: heart-valve, non-allograft tissue
Approval order statement: Approval of the protocol for the post-approval study (PAS) titled "EHR-Based New Enrollment Study." The PAS protocol was submitted to comply with the conditions of approval outlined in the approval order for P150048/S092.

Current openFDA PMA Record#

Device: TRIFORMIS RESILIA Tricuspid Valve, Model 11300T
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S097
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2026-02-06
Decision code: APPR
Date received: 2026-01-07
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the protocol for the post-approval study (PAS) titled "EHR-Based New Enrollment Study." The PAS protocol was submitted to comply with the conditions of approval outlined in the approval order for P150048/S092.