SURGIFOAM ABSORBABLE GELATIN SPONGE
FDA premarket approval P990004/S012 · decided 2007-12-13
Approval details
- PMA number
- P990004
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SURGIFOAM ABSORBABLE GELATIN SPONGE
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2007-06-20
- Decision date
- 2007-12-13
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- APPROVAL FOR THE ADDITION OF CLINICAL RESULTS TO THE PRODUCT LABELING WITH AN UPDATE TO THE DIRECTIONS FOR USE TO ALLOW USE IN ENDOSCOPIC NASAL SINUS SURGERY AND ADDITION OF A BENDABLE APPLICATOR TIP (FLEXTIP). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURGIFOAM ABSORBABLE GELATIN SPONGE, U.S.P. AND IS INDICATED FOR AN ADJUNCT TO HEMOSTASIS DURING SURGICAL PROCEDURES.
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