SURGIFOAM ABSORBABLE GELATIN SPONGE, USP
FDA premarket approval P990004/S001 · decided 1999-12-02
Approval details
- PMA number
- P990004
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SURGIFOAM ABSORBABLE GELATIN SPONGE, USP
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 1999-11-15
- Decision date
- 1999-12-02
- Days to decision
- 17 days
- Decision code
- APPR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- Approval for the addition of sponges 3mm and 7mm thick.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.