- Device
- Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic Bioprosthesis with ThermaFix tis
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S182
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2018-07-26
- Decision code
- OK30
- Date received
- 2018-07-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new cleaning process utilizing an ultrasonic cleaner for surgical heart valve polyester support bands.