BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P050043 · Supplement: S002 · Decision Jul 24, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    7F FISH-SP DEVICE
    PMA Number
    P050043
    Supplement Number
    S002
    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
    July 24, 2009
    Date Received
    May 26, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF THE 7F FISH-SP DEVICE TO THE FISH PRODUCT LINE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME 7F FISH-SP DEVICE FOR CLOSURE AND IS INDICATED FOR PERCUTANEOUS ACCESS AND CLOSURE OF THE COMMON FEMORAL ARTERY WHILE REDUCING TIME TO HEMOSTASIS, AMBULATION AND TIME TO ELIGIBLE DISCHARGE IN PATIENTS REQUIRING ACCESS OF 7F FOR ENDOVASCULAR PROCEDURE WITH SHEATH REMOVAL.

    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