Masters Series, Masters Series HP, Regent, Masters Series Aortic Valved Graft with Hemashield graft technology
FDA premarket approval P810002/S121 · decided 2024-04-03
Approval details
- PMA number
- P810002
- Supplement
- S121
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Masters Series, Masters Series HP, Regent, Masters Series Aortic Valved Graft with Hemashield graft technology
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- ABBOTT MEDICAL
- Date received
- 2024-01-23
- Decision date
- 2024-04-03
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- for implementing rebranding of the SJM Masters Series Mechanical Heart Valve, SJM Regent Mechanical Heart Valve, and SJM Masters Valved Graft with Hemashield graft technology.
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