BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Absorbable Hemostatic, Collagen Based

    PMA: N18286 · Supplement: S018 · Decision Jun 10, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Agent, Absorbable Hemostatic, Collagen Based
    Trade Name
    GELFOAM PLUS HEMOSTASIS KIT
    PMA Number
    N18286
    Supplement Number
    S018
    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
    June 10, 2009
    Date Received
    February 26, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF CHANGES TO THE MANUFACTURING OF THE HUMAN THROMBIN COMPONENT OF THE GELFOAM PLUS HEMOSTASIS KIT THROUGH THE ADDITION OF A SOLVENT/ DETERGENT STEP (HUMAN THROMBIN VH S/D). THE THROMBIN IS TO BE MANUFACTURED AND SUPPLIED BY BAXTER HEALTHCARE CORPORATION.

    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