- Device
- Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis, PERIMOUNT Magna Pericardial Aortic BIoprosthesis wi
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S181
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2018-07-27
- Decision code
- OK30
- Date received
- 2018-07-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Increase in the number of frames and valve holders ultrasonically cleaned per load.