BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Fluid, Hysteroscopy

    PMA: P880028 · Decision May 30, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Fluid, Hysteroscopy
    Trade Name
    DEXTRAN HM 32%
    PMA Number
    P880028
    Device Class
    FDA Class 3
    Product Code
    LTA
    Generic Name
    FLUID, HYSTEROSCOPY
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    May 30, 1989
    Date Received
    April 12, 1988
    Expedited Review
    N
    Docket Number
    89M-0194

    Classifications

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

    Product Code Device Name
    LTA Fluid, Hysteroscopy