SURGIFOAM® Absorbable Gelatin Sponge, SURGIFOAM® Absorbable Gelatin Powder, SURGIFOAM® Absorbable Gelatin Powder Kit, SU
FDA premarket approval P990004/S056 · decided 2023-01-31
Approval details
- PMA number
- P990004
- Supplement
- S056
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGIFOAM® Absorbable Gelatin Sponge, SURGIFOAM® Absorbable Gelatin Powder, SURGIFOAM® Absorbable Gelatin Powder Kit, SU
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2022-07-01
- Decision date
- 2023-01-31
- Days to decision
- 214 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- Approval for implementation of a new gelatin processing line (consisting of a gelatin preparation tank, whipping equipment and plating head and table) and three (3) new drying ovens.
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