SURGIFOAM Absorbable Gelatin Sponge, U.S.P.
FDA premarket approval P990004/S045 · decided 2021-08-13
Approval details
- PMA number
- P990004
- Supplement
- S045
- Supplement type
- 135 Review Track For 30-Day Notice
- 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
- 2021-02-19
- Decision date
- 2021-08-13
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- Approval for a change in the reference to the drug master file (DMF) for the syringe pre-filled sterile water for injection (sWFI) used in the SURGIFOAM Absorbable Gelatin Sponge (U.S.P.).
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