SURGIFOAM Absorbable Gelation Sponge, U.S.P.
FDA premarket approval P990004/S048 · decided 2021-06-02
Approval details
- PMA number
- P990004
- Supplement
- S048
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGIFOAM Absorbable Gelation Sponge, U.S.P.
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2021-05-03
- Decision date
- 2021-06-02
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- Change to the supplier location of gamma irradiation services for dose audit samples.
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