- Device
- Masters Series Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Series Aortic Valved Graft with Hemashield
- Applicant
- ABBOTT MEDICAL
- PMA number
- P810002
- Supplement
- S124
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2025-02-20
- Decision code
- APPR
- Date received
- 2024-11-22
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for minor updates to the Masters Series Mechanical Heart Valve, Regent Mechanical Heart Valve, and Masters Series Aortic Valved Graft with Hemashield Graft Technology labeling to align with ISO 5840-2:2021 recommendations