- Device
- Carpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Theon RSR Pericardial
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S194
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2019-11-24
- Decision code
- OK30
- Date received
- 2019-11-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to down classify gowning room 129 from ISO Class 7 to ISO Class 8 at the Irvine facility