SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.
FDA premarket approval P990004/S049 · decided 2021-08-25
Approval details
- PMA number
- P990004
- Supplement
- S049
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2021-07-26
- Decision date
- 2021-08-25
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- Approval for implementation of a new additional strategy for monitoring of the endotoxin levels in raw materials, components, intermediates and finished products at Ferrosan Medical Devices A/S
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.