BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P930038 · Supplement: S027 · Decision Oct 31, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    ANGIO-SEAL(TM) EV VASCULAR CLOSURE DEVICE/8 AND 6 FRENCH
    PMA Number
    P930038
    Supplement Number
    S027
    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
    October 31, 2000
    Date Received
    October 2, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A DEVICE NAME MODIFICATION AND LONGER GUIDEWIRE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIO-SEAL(TM) ACCESS CLOSURE FOLLOWING 8F AND 6F DIAGNOSTIC ANGIOGRAPHY AND INTERVENTIONAL (8F ONLY) 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