BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P920004 · Supplement: S008 · Decision Dec 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    VASOSEAL ES DEVICE
    PMA Number
    P920004
    Supplement Number
    S008
    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
    December 11, 1998
    Date Received
    November 13, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to market a modified version of the VasoSeal(R) Vascular Hemostasis Device. The device, as modified, will be marketed under the trade name VasoSeal(R) Extra Security (ES) Device and is indicated for reducing time to hemostasis at the femoral arterial puncture site and in reducing time to ambulation in patients who have undergone diagnostic angiography or interventional procedures.

    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