PMA P150048S037

Device: Edwards Pericardial Aortic/Mitral Bioprosthesis and Edwards Inspiris Resilia Aortic Valve
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S037
Product code: LWR
Decision date: 2019-09-24
Classification: Heart-valve, Non-allograft Tissue
Generic name: heart-valve, non-allograft tissue
Approval order statement: Expansion of the Heart Valve Center Chemical Mixing Suite and increased manning of the Chemical Mixing Suite at the Irvine facility.

Current openFDA PMA Record#

Device: Edwards Pericardial Aortic/Mitral Bioprosthesis and Edwards Inspiris Resilia Aortic Valve
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S037
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2019-09-24
Decision code: OK30
Date received: 2019-08-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Expansion of the Heart Valve Center Chemical Mixing Suite and increased manning of the Chemical Mixing Suite at the Irvine facility.