PMA P810002S114
- Device
- BILEAFLET-CENTER OPENING CARDIAC VALVE
- Applicant
- ABBOTT MEDICAL
- PMA number
- P810002
- Supplement
- S114
- Product code
- LWQ
- Decision date
- 2021-10-20
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- New detergent in the manufacture of cuff fabric and vascular graft components.
Current openFDA PMA Record#
- Device
- BILEAFLET-CENTER OPENING CARDIAC VALVE
- Applicant
- ABBOTT MEDICAL
- PMA number
- P810002
- Supplement
- S114
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2021-10-20
- Decision code
- OK30
- Date received
- 2021-09-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New detergent in the manufacture of cuff fabric and vascular graft components.