PMA P860057S205
- Device
- Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwards
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S205
- Product code
- DYE
- Decision date
- 2021-11-18
- Generic name
- replacement Heart-valve
- Approval order statement
- Addition of new cleanroom.
Current openFDA PMA Record#
- Device
- Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwards
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S205
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2021-11-18
- Decision code
- OK30
- Date received
- 2021-10-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of new cleanroom.