- Device
- Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis 3000, with ThermaFix tissue process 3000TFX,Ease Per
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S152
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2016-10-20
- Decision code
- APPR
- Date received
- 2016-08-12
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling changes related to MR compatibility and minor clarifications to the implant procedure.