PMA P860057S190
- Device
- Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis, Theon Pericardial Aortic Bioprosthesis with ThermaFix tis
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S190
- Product code
- DYE
- Decision date
- 2019-06-11
- Classification
- Replacement Heart-valve
- Generic name
- replacement Heart-valve
- Approval order statement
- Removal of two redundant visual inspections for valve leaflets.
Current openFDA PMA Record#
- Device
- Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis, Theon Pericardial Aortic Bioprosthesis with ThermaFix tis
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S190
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2019-06-11
- Decision code
- OK30
- Date received
- 2019-05-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of two redundant visual inspections for valve leaflets.