SURGIFOAM® Absorbable Gelatin Sponge, U.S.P., Dental Sponge, SURGIFOAM® Absorbable Gelatin Sponge, U.S.P., Hemorrhoidect
FDA premarket approval P990004/S051 · decided 2021-12-21
Approval details
- PMA number
- P990004
- Supplement
- S051
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGIFOAM® Absorbable Gelatin Sponge, U.S.P., Dental Sponge, SURGIFOAM® Absorbable Gelatin Sponge, U.S.P., Hemorrhoidect
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2021-11-22
- Decision date
- 2021-12-21
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- Change to the Electron beam (E-beam) equipment located at the current E-beam contract sterilization site for the SURGIFOAM® Absorbable Gelatin Dental Sponge, the SURGIFOAM® Absorbable Gelatin Hemorrhoidectomy Sponge, and the SURGIFOAM® Absorbable Gelatin Powder.
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