SURGIFOAM Absorbable Gelatin Sponge, U.S.P.
FDA premarket approval P990004/S039 · decided 2021-10-19
Approval details
- PMA number
- P990004
- Supplement
- S039
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location 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
- 2020-05-22
- Decision date
- 2021-10-19
- Days to decision
- 515 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- Approval for addition of an alternate sterilization site and a change to the sterilization dosage for SURGIFOAM Absorbable Gelatin Sponge (Oral Sponge and Hemorrhoidectomy Sponge) and SURGIFOAM® Absorbable Gelatin Powder
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