BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P040044 · Decision Aug 17, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    MATRIX VASCULAR CLOSURE SYSTEM (VSG)
    PMA Number
    P040044
    Device Class
    FDA Class 3
    Product Code
    MGB
    Generic Name
    Device, hemostasis, vascular
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 17, 2005
    Date Received
    November 4, 2004
    Expedited Review
    N
    Docket Number
    05M-0359

    Advisory Committee Statement

    APPROVAL FOR THE MATRIX VSG SYSTEM, MODEL MX-100. THE DEVICE IS INDICATED FOR USE TO SEAL FEMORAL ARTERIAL ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES UTILIZING A 5F, 6F, OR 7F PROCEDURAL SHEATH.

    Classifications

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

    Product Code Device Name
    MGB Device, Hemostasis, Vascular