PMA P150048S099

Device: INSPIRIS RESILIA Aortic Valve, MITRIS RESILIA Mitral Valve, KONECT RESILIA Aortic Valved Conduit
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S099
Product code: LWR
Decision date: 2026-04-16
Classification: Cardiovascular
Generic name: heart-valve, non-allograft tissue
Approval order statement: an alternative method to process devices prior to RESILIA treatment, and cleanroom modifications to accommodate this alternative processing method

Current openFDA PMA Record#

Device: INSPIRIS RESILIA Aortic Valve, MITRIS RESILIA Mitral Valve, KONECT RESILIA Aortic Valved Conduit
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S099
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2026-04-16
Decision code: OK30
Date received: 2026-03-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an alternative method to process devices prior to RESILIA treatment, and cleanroom modifications to accommodate this alternative processing method