BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Absorbable Hemostatic, Collagen Based

    PMA: N18286 · Supplement: S017 · Decision Dec 13, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Agent, Absorbable Hemostatic, Collagen Based
    Trade Name
    GELFOAM PLUS HEMOSTATIC KIT
    PMA Number
    N18286
    Supplement Number
    S017
    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
    December 13, 2007
    Date Received
    May 24, 2007
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW KIT CONFIGURATION TO INCLUDE HUMAN THROMBIN. THE KIT IS TO BE PREPARED AT THE BAXTER HEALTHCARE CORPORATION PLANT IN HAYWARD, CALIFORNIA. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GELFOAM PLUS HEMOSTASIS KIT AND 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.

    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