BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lipoprotein, Low Density, Removal

    PMA: P940016 · Supplement: S015 · Decision Feb 22, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Lipoprotein, Low Density, Removal
    Trade Name
    H.E.L.P. PLASMAT FUTURA SYSTEM
    PMA Number
    P940016
    Supplement Number
    S015
    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
    February 22, 2013
    Date Received
    December 20, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN INCREASE IN MEMBRANE LENGTH AND AN INCREASE INHOUSING LENGTH OF THE HEPARIN ADSORBER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEPARIN ADSORBER 400 AND IS INDICATED FOR USE AS A COMPONENT OF THE H.E.L.P FUTURA APHERESIS SYSTEM, USED FOR THE REMOVAL, BY IONIC EXCHANGE, OF EXCESS HEPARIN ADDED TO PRECIPITATE LIPOPROTEINS FROM PLASMA.

    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