- Device
- Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwar
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S203
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2021-09-08
- Decision code
- OK30
- Date received
- 2021-08-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduction of the number of in-process glutaraldehyde solution change-outs for surgical pericardial heart valves.