PMA P860057S217
- Device
- Carpentier-Edwards® PERIMOUNT Family of Pericardial Bioprostheses
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S217
- Product code
- DYE
- Decision date
- 2024-03-25
- Classification
- Cardiovascular
- Generic name
- replacement Heart-valve
- Approval order statement
- replacement of a manual inspection with a manufacturing aid to measure the amount of solution present in packaging jars
Current openFDA PMA Record#
- Device
- Carpentier-Edwards® PERIMOUNT Family of Pericardial Bioprostheses
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P860057
- Supplement
- S217
- Product code
- DYE
- Generic name
- replacement Heart-valve
- Decision date
- 2024-03-25
- Decision code
- OK30
- Date received
- 2024-03-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- replacement of a manual inspection with a manufacturing aid to measure the amount of solution present in packaging jars