BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluid, Hysteroscopy

    PMA: P880028 · Supplement: S006 · Decision Jan 4, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Fluid, Hysteroscopy
    Trade Name
    DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM
    PMA Number
    P880028
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    LTA
    Generic Name
    FLUID, HYSTEROSCOPY
    Medical Specialty
    Unknown
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 4, 1996
    Date Received
    November 17, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ALTERNATE MANUFACTURING FACILITY WITH ROQUEETE AMERICA, INC. IN KEOKUK, IOWA, FOR DEXTROSE USP. HYDROUS BULK DRUG AS A COMPONENT OF DEXTROSE HM 32%

    Classifications

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

    Product Code Device Name
    LTA Fluid, Hysteroscopy