SURGIFOAM, Absorbable Gelatin Sponge U.S.P.
FDA premarket approval P990004/S034 · decided 2019-07-24
Approval details
- PMA number
- P990004
- Supplement
- S034
- Supplement type
- 135 Review Track For 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
- 2019-02-04
- Decision date
- 2019-07-24
- Days to decision
- 170 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- Approval for a change in the detergent used for the washing/rising cycles in the washing machine in the production of the SURGIFOAM Absorbable Gelatin Sponge.
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