- Device
- Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix® tissue process; Carpentier-Edwar
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S079
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2026-03-11
- Decision code
- OK30
- Date received
- 2026-02-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- alternate suppliers of solutions used in the manufacturing process of transcatheter and surgical heart valves