PMA P150048S017

Device: Edwards Pericardial Aortic Bioprosthesis and Inspiris Resilia Aortic
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S017
Product code: LWR
Decision date: 2018-02-28
Classification: Heart-valve, Non-allograft Tissue
Generic name: heart-valve, non-allograft tissue
Approval order statement: Add a new clean room for the manufacture of the Edwards Integrity Preservation technology for the RESILIA tissue.

Current openFDA PMA Record#

Device: Edwards Pericardial Aortic Bioprosthesis and Inspiris Resilia Aortic
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S017
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2018-02-28
Decision code: OK30
Date received: 2018-02-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Add a new clean room for the manufacture of the Edwards Integrity Preservation technology for the RESILIA tissue.