- Device
- Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis/Theon Pericardial Aortic Bioprosthesis with ThermaFix tiss
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S186
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2018-12-03
- Decision code
- OK30
- Date received
- 2018-11-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the glutaraldehyde solution system including additional storage tanks.