- Device
- Carpentier-Edwards PERIMOUNT Magna Ease Aortic Heart Valve, Carpentier-Edwards PERIMOUNT Magna Mitral Ease Bioprosthesis
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S225
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2026-04-16
- Decision code
- OK30
- Date received
- 2026-03-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternative method to process devices prior to RESILIA treatment, and cleanroom modifications to accommodate this alternative processing method