- Device
- CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPPROSTHESIS, THEON WITH THERMAFIX TISSUE PROCESS; RSR, THEON RSR WITH
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S129
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2014-11-14
- Decision code
- OK30
- Date received
- 2014-10-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- NEW ENCLOSURE AND EQUIPMENT TO BE USED IN THE PARTICULATE EVALUATION PROCESS OF COMPONENTS.