SURGIFOAM HEMOSTATIC MATRIX KIT
FDA premarket approval P990004/S017 · decided 2011-05-31
Approval details
- PMA number
- P990004
- Supplement
- S017
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SURGIFOAM HEMOSTATIC MATRIX KIT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2010-03-02
- Decision date
- 2011-05-31
- Days to decision
- 455 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- APPROVAL FOR CHANGES TO THE RECONSTITUTION OF METHOD FOR THE THROMBIN COMPONENT AND MODIFIED THE METHOD OF MIXING WITH THE POWDERED GELATIN COMPONENT.
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