SURGIFOAM® Absorbable Gelatin Sponge
FDA premarket approval P990004/S076 · decided 2025-09-08
Approval details
- PMA number
- P990004
- Supplement
- S076
- 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
- 2025-08-11
- Decision date
- 2025-09-08
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Soeborg
- Statement
- the implementation of an additional Syringe Assembly machine to increase production capacity for SURGIFLOW Hemostatic Matrix Kit and SURGIFLOW Hemostatic Matrix Kit with Thrombin productsThe proposed change qualifies for 30-Day Notice because it involves: Implementation and use of an additional Syringe Assembly machine. Manufacturing method/process change only. Capacity increase for existing products.This manufacturing change meets FDA criteria for 30-Day Notice submission because it's a ma
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