PMA P150048S028

Device: Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S028
Product code: LWR
Decision date: 2018-11-19
Classification: Heart-valve, Non-allograft Tissue
Generic name: heart-valve, non-allograft tissue
Approval order statement: Utilization of a portion of a new controlled environment as an additional storage area for processed pericardial tissue leaflets.

Current openFDA PMA Record#

Device: Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S028
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2018-11-19
Decision code: OK30
Date received: 2018-10-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Utilization of a portion of a new controlled environment as an additional storage area for processed pericardial tissue leaflets.