SURGIFLO HEMOSTATIC MATRIX KIT
FDA premarket approval P990004/S016 · decided 2009-10-02
Approval details
- PMA number
- P990004
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SURGIFLO HEMOSTATIC MATRIX KIT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2009-07-06
- Decision date
- 2009-10-02
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- APPROVAL FOR PERMISSION TO MARKET THE SURGIFLO HEMOSTATIC MATRIX KIT CONSISTING OF THE SURGIFLO HEMOSTATIC MATRIX AND EVITHROM LYOPHILIZED HUMAN THROMBIN.
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