BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Device, Vascular, For Promoting Embolization

    PMA: P780011 · Supplement: S012 · Decision Oct 30, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96

    Basic Information

    Device Name
    Device, Vascular, For Promoting Embolization
    Trade Name
    MINI BALLOON
    PMA Number
    P780011
    Supplement Number
    S012
    Device Class
    FDA Class 2
    Product Code
    KRD
    Generic Name
    Device, Vascular, for Promoting Embolization
    Regulation Number
    870.3300
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 30, 1989
    Date Received
    August 29, 1989
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KRD Device, Vascular, For Promoting Embolization