SURGIFOAM Absorbable Gelatin Sponge U.S.P.
FDA premarket approval P990004/S042 · decided 2020-08-27
Approval details
- PMA number
- P990004
- Supplement
- S042
- Supplement type
- Special (Immediate Track)
- 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
- 2020-07-30
- Decision date
- 2020-08-27
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- Approval for implementation of a water sample monitoring program for the washing machines used to wash items used for the manufacturing of SURGIFOAM Absorbable Gelatin Sponge, SURGIFOAM Absorbable Gelatin Powder and SURGIFLO Hemostatic Matrix.
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