- Device
- Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Theon Pericardial Aortic Bioprosthesis with ThermaFix tis
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S183
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2018-11-20
- Decision code
- OK30
- Date received
- 2018-10-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of the visual inspection for “Open Leaflet” in air for surgical pericardial heart valves.