- Device
- Masters Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Valved Graft with Hemashield™ graft technology (C
- Applicant
- ABBOTT MEDICAL
- PMA number
- P810002
- Supplement
- S116
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2023-01-27
- Decision code
- OK30
- Date received
- 2022-12-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the supplier of resin material used in manufacturing mechanical heart valve fabric and conduit components.