BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluid, Hysteroscopy

    PMA: N17511 · Supplement: S012 · Decision Dec 30, 1997
    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
    S012
    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
    December 30, 1997
    Date Received
    December 1, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing facility located at NPBI, Nederlands Produktielaboratorium Voor, Bloedtransfusieapparatuur en Infusievloeistoffen B.V., Runde ZZ 41, 7881 HM Emmer-Compascuum, The Netherlands.

    Classifications

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

    Product Code Device Name
    LTA Fluid, Hysteroscopy