PMA P150048S093

Device: INSPIRIS RESILIA Aortic Valve; MITRIS RESILIA Mitral Valve
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S093
Product code: LWR
Decision date: 2025-10-16
Classification: Cardiovascular
Generic name: heart-valve, non-allograft tissue
Approval order statement: addition of final bioburden reduction and preliminary packaging processes to an existing cleanroom, and increased maximum capacity in the cleanroom

Current openFDA PMA Record#

Device: INSPIRIS RESILIA Aortic Valve; MITRIS RESILIA Mitral Valve
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S093
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2025-10-16
Decision code: OK30
Date received: 2025-09-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of final bioburden reduction and preliminary packaging processes to an existing cleanroom, and increased maximum capacity in the cleanroom