PMA P810002S117
- Device
- BILEAFLET-CENTER OPENING CARDIAC VALVE
- Applicant
- ABBOTT MEDICAL
- PMA number
- P810002
- Supplement
- S117
- Product code
- LWQ
- Decision date
- 2023-03-28
- Classification
- Cardiovascular
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- New supplier of polishing media used in mechanical heart valve manufacturing.
Current openFDA PMA Record#
- Device
- BILEAFLET-CENTER OPENING CARDIAC VALVE
- Applicant
- ABBOTT MEDICAL
- PMA number
- P810002
- Supplement
- S117
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2023-03-28
- Decision code
- OK30
- Date received
- 2023-02-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New supplier of polishing media used in mechanical heart valve manufacturing.