BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lipoprotein, Low Density, Removal

    PMA: P940016 · Supplement: S014 · Decision Jan 13, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Lipoprotein, Low Density, Removal
    Trade Name
    HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM
    PMA Number
    P940016
    Supplement Number
    S014
    Device Class
    FDA Class 3
    Product Code
    MMY
    Generic Name
    Lipoprotein, low density, removal
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 13, 2012
    Date Received
    July 19, 2011
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE POTTING RESIN USED TO ANCHOR THE MEMBRANES OF THE HEPARIN ADSORBER AND THE PLASMAFILTER HAEMOSELECT COMPONENTS OF THE SYSTEM.

    Classifications

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

    Product Code Device Name
    MMY Lipoprotein, Low Density, Removal