SURGIFOAM ABSORBABLE GELATIN SPONGE, USP
FDA premarket approval P990004 · decided 1999-09-30
Approval details
- PMA number
- P990004
- Trade name
- SURGIFOAM ABSORBABLE GELATIN SPONGE, USP
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 1999-01-22
- Decision date
- 1999-09-30
- Days to decision
- 251 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- Approval for the SURGIFOAM Absorbable Gelatin Sponge, U.S.P. This device is indicated for surgical procedures (except urologic, ophthalmic and neurologic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.