PMA P150048S039

Device: Edwards Pericardial Aortic Bioprosthesis, Inspiris Resilia Aortic Valve, and Edwards Pericardial Mitral Bioprosthesis
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S039
Product code: LWR
Decision date: 2019-10-28
Classification: Heart-valve, Non-allograft Tissue
Generic name: heart-valve, non-allograft tissue
Approval order statement: Modifications to the final assembly cleanroom and the associated gowning room.

Current openFDA PMA Record#

Device: Edwards Pericardial Aortic Bioprosthesis, Inspiris Resilia Aortic Valve, and Edwards Pericardial Mitral Bioprosthesis
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S039
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2019-10-28
Decision code: OK30
Date received: 2019-10-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modifications to the final assembly cleanroom and the associated gowning room.