PMA P150048S060

Device: Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve
Applicant: Edwards Lifesciences, LLC
Product code: LWR
Decision date: 2022-12-29
Generic name: heart-valve, non-allograft tissue
Approval order statement: Approval for a manufacturing site located at 35 Changi North Crescent, Changi, Singapore, 499641 for RESILIA/GLX processing and final packaging of the INSPIRIS RESILIA Aortic Valves, as well as an alternate ethylene oxide sterilization site at Sterile Services Singapore, 47 Jaran Buroh Unit #01-01, Singapore South West, Singapore 619491.

Current openFDA PMA Record#

Device: Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S060
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2022-12-29
Decision code: APPR
Date received: 2022-02-04
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at 35 Changi North Crescent, Changi, Singapore, 499641 for RESILIA/GLX processing and final packaging of the INSPIRIS RESILIA Aortic Valves, as well as an alternate ethylene oxide sterilization site at Sterile Services Singapore, 47 Jaran Buroh Unit #01-01, Singapore South West, Singapore 619491.