BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Absorbable Hemostatic, Collagen Based

    PMA: N18286 · Supplement: S024 · Decision Jan 7, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Agent, Absorbable Hemostatic, Collagen Based
    Trade Name
    GELFOAM (ABSORABLE GELATIN) POWDER, USP
    PMA Number
    N18286
    Supplement Number
    S024
    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
    Approved
    Decision Code
    APPR
    Decision Date
    January 7, 2013
    Date Received
    November 26, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MINOR CHANGE IN LABELING INSTRUCTIONS TO INCLUDE MIXING GELFOAM POWDER WITH DILUENTS OF SALINE FOR INJECTION OR THROMBIN. NO OTHER CHANGE INCLUDED IN THIS APPROVAL ORDER. THE DEVICE ALONG WITH THE MODIFIED LABELING WILL BE MARKETED UNDER THE TRADE NAME GELFOAM ABSORBABLE GELATIN POWDER: IS INTENDED AS A HEMOSTATIC DEVICE FOR SURGICAL PROCEDURES WHEN CONTROL OF CAPILLARY, VENOUS AND ARTERIOLAR BLEEDING BY PRESSURE, LIGATURE, AND OTHER CONVENTIONAL PROCEDURES IS EITHER INEFFECTIVE OR IMPRACTICAL. ALTHOUGH NOT NECESSARY, GELFOAM STERILE POWDER CAN BE USED EITHER WITH OR WITHOUT THROMBIN TO OBTAIN HEMOSTASIS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LMF Agent, Absorbable Hemostatic, Collagen Based