SURGIFOAM® Absorbable Gelatin Sponge
FDA premarket approval P990004/S074 · decided 2025-05-27
Approval details
- PMA number
- P990004
- Supplement
- S074
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SURGIFOAM® Absorbable Gelatin Sponge
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Ferrosan Meidcal Devices A/S
- Date received
- 2025-04-29
- Decision date
- 2025-05-27
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- expansion of the cleanroom area to be used for assembly of syringes used in SURGIFLO Intermediate at Ferrosan Medical Devices A/S (FeMD)
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