PMA P860057S215
- Device
- Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Biopr
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S215
- Product code
- DYE
- Decision date
- 2023-12-06
- Classification
- Cardiovascular
- Generic name
- replacement Heart-valve
- Approval order statement
- alternative suppliers for chemicals used in a high-level disinfectant
Current openFDA PMA Record#
- Device
- Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Biopr
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S215
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2023-12-06
- Decision code
- OK30
- Date received
- 2023-11-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- alternative suppliers for chemicals used in a high-level disinfectant