SURGIFLO Hemostatic Matrix Kit with Thrombin
FDA premarket approval P990004/S044 · decided 2021-06-18
Approval details
- PMA number
- P990004
- Supplement
- S044
- Supplement type
- Real-Time Process
- 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
- 2021-02-04
- Decision date
- 2021-06-18
- Days to decision
- 134 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- Approval for the modification to the sterile Water for Injection (sWFI) needle-free prefilled syringe in the SURGIFLO Hemostatic Matrix Kit with Thrombin
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