- Device
- Carpentier-Edwards PERIMOUNT Aortic Pericardial Bioprosthesis with ThermaFix tissue process, Carpentier-Edwards PERIMOUN
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S218
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2024-05-23
- Decision code
- OK30
- Date received
- 2024-04-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- alternate chemical suppliers for bioprosthetic heart valve manufacturing