- Device
- Carpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Theon RSR Pericardial
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S193
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2019-11-18
- Decision code
- OK30
- Date received
- 2019-10-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Supplier Southington Tool and Manufacturing Corporation (STMC) to perform wireform crimping and tensile test verification.