PMA P150048S098

Device: INSPIRIS™ RESILIA™ Aortic Valve; KONECT RESILIA Aortic Valve Conduit (AVC); MITRIS RESILIA Mitral Valve
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S098
Product code: LWR
Decision date: 2026-03-11
Classification: Cardiovascular
Generic name: heart-valve, non-allograft tissue
Approval order statement: alternate suppliers of solutions used in the manufacturing process of transcatheter and surgical heart valves

Current openFDA PMA Record#

Device: INSPIRIS™ RESILIA™ Aortic Valve; KONECT RESILIA Aortic Valve Conduit (AVC); MITRIS RESILIA Mitral Valve
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S098
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2026-03-11
Decision code: OK30
Date received: 2026-02-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: alternate suppliers of solutions used in the manufacturing process of transcatheter and surgical heart valves