BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P930038 · Decision Sep 30, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    Angio Seal Vascular Closure Device
    PMA Number
    P930038
    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 30, 1996
    Date Received
    October 28, 1993
    Expedited Review
    N
    Docket Number
    97M-0259

    Advisory Committee Statement

    APPROVAL FOR THE ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE 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