Agent, Absorbable Hemostatic, Collagen Based
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Basic Information
- Device Name
- Agent, Absorbable Hemostatic, Collagen Based
- Trade Name
- SURGIFOAM® Absorbable Gelatin Sponge
- PMA Number
- P990004
- Supplement Number
- S076
- Device Class
- FDA Class 3
- Product Code
- LMF
- Generic Name
- Agent, absorbable hemostatic, collagen based
- Regulation Number
- 878.4490
- Medical Specialty
- General, Plastic Surgery
- Advisory Committee
- General, Plastic Surgery
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- September 8, 2025
- Date Received
- August 11, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee 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 manufacturing capacity addition that maintains identical product specifications without impacting intended device safety, effectiveness, or characteristics. The change is operational (additional assembly location) rather than modification (product alteration).
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LMF | Agent, Absorbable Hemostatic, Collagen Based | FDA class 3 | General, Plastic Surgery |