PMA P860057S184

Device: Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Theon Pericardial Aortic Bioprosthesis with ThermaFix tis
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S184
Product code: DYE
Decision date: 2018-11-19
Classification: Replacement Heart-valve
Generic name: replacement Heart-valve
Approval order statement: Utilization of a portion of a new controlled environment as an additional storage area for processed pericardial tissue leaflets.

Current openFDA PMA Record#

Device: Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Theon Pericardial Aortic Bioprosthesis with ThermaFix tis
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S184
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2018-11-19
Decision code: OK30
Date received: 2018-10-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Utilization of a portion of a new controlled environment as an additional storage area for processed pericardial tissue leaflets.