- Device
- Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S189
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2020-01-15
- Decision code
- APPR
- Date received
- 2019-05-23
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the use of the dry plant quality laboratory for routine environmental and manufacturing solution monitoring.