SURGIFOAM ABSORBABLE GELATIN SPONGE, USP, ORAL SPONGE
FDA premarket approval P990004/S010 · decided 2006-10-03
Approval details
- PMA number
- P990004
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SURGIFOAM ABSORBABLE GELATIN SPONGE, USP, ORAL SPONGE
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2006-08-30
- Decision date
- 2006-10-03
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- APPROVAL FOR AN ORAL SURGERY FORM OF SURGIFOAM ABSORBABLE GELATIN SPONGE, USP. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGIFOAM ABSORBABLE GELATIN SPONGE, USP, ORAL SPONGE AND IS INDICATED FOR USE AS AN ADJUNCT TO HEMOSTASIS DURING SURGICAL PROCEDURES.
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