PMA P860057S219

Device: Carpentier-Edwards PERIMOUNT Aortic Pericardial Bioprosthesis with ThermaFix tissue process, Carpentier-Edwards PERIMOUN
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S219
Product code: DYE
Decision date: 2024-09-12
Classification: Cardiovascular
Generic name: replacement Heart-valve
Approval order statement: outsourcing of PTFE cloth manufacturing and sutures/threads re-spooling (used in valve manufacturing) to a new supplier

Current openFDA PMA Record#

Device: Carpentier-Edwards PERIMOUNT Aortic Pericardial Bioprosthesis with ThermaFix tissue process, Carpentier-Edwards PERIMOUN
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S219
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2024-09-12
Decision code: OK30
Date received: 2024-08-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: outsourcing of PTFE cloth manufacturing and sutures/threads re-spooling (used in valve manufacturing) to a new supplier