BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P050007 · Supplement: S003 · Decision Sep 22, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    STARCLOSE VASCULAR CLOSURE SYSTEM
    PMA Number
    P050007
    Supplement Number
    S003
    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
    September 22, 2006
    Date Received
    July 5, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) INCREASING THE RADII OF THE DISTAL END OF THE SUPPORT TUBE (CLIP DELIVERY TUBE) FROM 0.002 INCHES TO 0.004 INCHES; 2) ADDING A 45 DEGREE CHAMFER TO THE PROXIMAL EDGE OF THE DISTAL RING; AND 3) REMOVING THE ?6F? NOTATION ON THE HANDLE OF THE DEVICE.

    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