- Device
- Perimount Bioprosthesis, Perimount Magna Aortic Bioprosthesis, Perimount Magna Ease Bioprosthesis, and Perimount Plus Bi
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S192
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2019-10-28
- Decision code
- OK30
- Date received
- 2019-10-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the final assembly cleanroom and the associated gowning room.