PMA P150048S068

Device: Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesi
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S068
Product code: LWR
Decision date: 2022-09-23
Generic name: heart-valve, non-allograft tissue
Approval order statement: Implementation of an enhanced temperature indicator packaging component to monitor surgical and transcatheter heart valves during transit and storage.

Current openFDA PMA Record#

Device: Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesi
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S068
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2022-09-23
Decision code: OK30
Date received: 2022-08-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of an enhanced temperature indicator packaging component to monitor surgical and transcatheter heart valves during transit and storage.