PMA P860057S187
- Device
- Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Theon Pericardial Aortic Bioprosthesis with ThermaFix tis
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S187
- Product code
- DYE
- Decision date
- 2019-03-03
- Classification
- Replacement Heart-valve
- Generic name
- replacement Heart-valve
- Approval order statement
- Increased manning in Cleanroom #4 at the Changi, Singapore facility.
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
- S187
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2019-03-03
- Decision code
- OK30
- Date received
- 2019-01-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Increased manning in Cleanroom #4 at the Changi, Singapore facility.