PMA P860057S210

Device: Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwards
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S210
Product code: DYE
Decision date: 2022-10-19
Generic name: replacement Heart-valve
Approval order statement: Change in yarn extruder and an additional bias cloth manufacturing step.

Current openFDA PMA Record#

Device: Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwards
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S210
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2022-10-19
Decision code: OK30
Date received: 2022-10-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change in yarn extruder and an additional bias cloth manufacturing step.