SURGIFOAM® Absorbable Gelatin Sponge, U.S.P.
FDA premarket approval P990004/S050 · decided 2021-10-28
Approval details
- PMA number
- P990004
- Supplement
- S050
- Supplement type
- 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
- 2021-09-28
- Decision date
- 2021-10-28
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- Use of an additional dry oven for the SURGIFOAM® pouch-packed sponge products to increase production capacity.
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