SURGIFLO Hemostatic Matrix Kit with Thrombin
FDA premarket approval P990004/S073 · decided 2025-07-09
Approval details
- PMA number
- P990004
- Supplement
- S073
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SURGIFLO Hemostatic Matrix Kit with Thrombin
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2025-04-10
- Decision date
- 2025-07-09
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- Approval for a line extension of SURGIFLO Hemostatic Matrix Kit with Thrombin
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