Surgifoam Absorbable Gelatin Sponge

FDA PMA

Class III (US FDA PMA)

PMA P990004

by Ferrosan Meidcal Devices A/S

Identity

Trade Name: SURGIFOAM ABSORBABLE GELATIN SPONGE, USP FDA PMA
Generic Name: Agent, absorbable hemostatic, collagen based FDA PMA

Identifiers

PMA Number: P990004 FDA PMA
FDA Product Code: LMF FDA PMA

Classification

Device Class: Class III FDA PMA
Legislation / Framework: 21 CFR Part 878.4490 FDA PMA
Regulation Number: 878.4490 FDA PMA
Advisory Committee: General, Plastic Surgery FDA PMA
FDA Decision: APPR Approved FDA PMA

Surgifoam Absorbable Gelatin Sponge is a collagen-based hemostatic agent designed to assist in surgical procedures. It is indicated for use when control of capillary, venous, and arteriolar bleeding by pressure, ligature, or other conventional methods is ineffective or impractical.

This device is intended for use in general and plastic surgery, excluding urologic, ophthalmic, and neurologic procedures. It has received FDA PMA authorization for its clinical application. Users should refer to the specific product labeling for information regarding sterility, storage, and application techniques.

Frequently asked questions

What is the primary use of Surgifoam Absorbable Gelatin Sponge?

The sponge is used as a hemostatic agent during surgical procedures to control bleeding from capillaries, veins, and arterioles when standard methods like pressure or ligature are not sufficient.

Are there any surgical areas where this device should not be used?

Yes, the device is not indicated for use in urologic, ophthalmic, or neurologic surgical procedures.

What is the regulatory status of this device?

Surgifoam Absorbable Gelatin Sponge has received FDA PMA authorization, which signifies that the device has undergone the premarket approval process required for class III medical devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA PMA	United States	FDA_PMA	P990004	Class III	Active

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Manufacturer

Manufacturer: Ferrosan Meidcal Devices A/S

Sources (1)

FDA PMA P990004 23 fields · synced Sep 18, 2026