BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lipoprotein, Low Density, Removal

    PMA: P940016 · Supplement: S013 · Decision Jul 22, 2010
    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 APHERESIS SYSTEM
    PMA Number
    P940016
    Supplement Number
    S013
    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
    July 22, 2010
    Date Received
    September 30, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR DESIGN MODIFICATIONS TO THE PLASMAT SECURA SYSTEM INCLUDING THE USE OF THE PLASMAT FUTURA MACHINE WITH SOFTWARE VERSION 2.6.01, THE FUTURA KIT, AND INDIVIDUALLY PACKAGED COMPONENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME H.E.L.P. PLASMAT FUTURA APHERESIS SYSTEM AND IS INDICATED FOR ACUTELY REMOVING LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C) FROM THE PLASMA OF THE FOLLOWING HIGH-RISK PATIENT POPULATIONS FOR WHOM DIET HAS BEEN INEFFECTIVE AND MAXIMUM DRUG THERAPY HAS EITHER BEEN INEFFECTIVE OR NOT TOLERATED:GROUP A: FUNCTIONAL HYPOCHOLESTEROL-EMIC HOMOZYGOTES WITH LDL-C > 500 MG/DL; GROUP B: FUNCTIONAL HYPOCHOLESTEROL-EMIC HOMOZYGOTES WITH LDL-C > 300 MG/DL; AND GROUP C: FUNCTIONAL HYPOCHOLESTEROL-EMIC HOMOZYGOTES WITH LDL-C > 200 MG/DL AND DOCUMENTED CORONARY ARTERY DISEASE.

    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