PMA P860057S209

Device: Carpentier-Edwards® PERIMOUNT ®Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S209
Product code: DYE
Decision date: 2022-09-23
Generic name: replacement Heart-valve
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: Carpentier-Edwards® PERIMOUNT ®Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S209
Product code: DYE
Generic name: replacement Heart-valve
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.