BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluid, Hysteroscopy

    PMA: N17511 · Supplement: S011 · Decision Jul 18, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Fluid, Hysteroscopy
    Trade Name
    HYSKON (32% DEXTRAN 70)
    PMA Number
    N17511
    Supplement Number
    S011
    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
    July 18, 1995
    Date Received
    November 10, 1994
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE USE OF A LAGARDE STERILIZER, 551015, IN YOUR CLAYTON, N.C. FACILITY TO TERMINALLY STERILIZE HYSKON HYSTEROSCOPY FLUID, 32% (DEXTRAN 70) IN 100 ML TO 250 ML GLASS BOTTLE:TRANSFER OF OWNERSHIP TO MADISAN PHARMACEUTICALS, INC.

    Classifications

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

    Product Code Device Name
    LTA Fluid, Hysteroscopy