BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Absorbable Hemostatic, Collagen Based

    PMA: N18286 · Supplement: S019 · Decision Apr 8, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Agent, Absorbable Hemostatic, Collagen Based
    Trade Name
    GELFOAM (ABSORBABLE GELATIN) PLUS HEMOSTATIS KIT
    PMA Number
    N18286
    Supplement Number
    S019
    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
    April 8, 2010
    Date Received
    March 17, 2010
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ADD A STATEMENT IN THE CONTRAINDICATIONS SECTION OF THE LABELING TO ADDRESS THE POTENTIAL RISK IN PATIENTS WITH KNOWN ALLERGIES TO PORCINE COLLAGEN.

    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