BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lipoprotein, Low Density, Removal

    PMA: P910018 · Supplement: S017 · Decision Jul 15, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Lipoprotein, Low Density, Removal
    Trade Name
    LIPOSORBER LA-15 SYSTEM
    PMA Number
    P910018
    Supplement Number
    S017
    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 15, 2015
    Date Received
    April 10, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFICATION OF THE INDICATIONS FOR USE OF THE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIPOSORBER® LA-15 SYSTEM AND IS INDICATED FOR USE IN PERFORMING LOW DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C) APHERESIS TO ACUTELY REMOVE 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: 1) GROUP A FUNCTIONAL HYPERCHOLESTEROLEMIC HOMOZYGOTES WITH LDL-C > 500 MG/DL; 2) GROUP B FUNCTIONAL HYPERCHOLESTEROLEMIC HETEROZYGOTES WITH LDL-C >= 300 MG/DL; AND 3) GROUP C FUNCTIONAL HYPERCHOLESTEROLEMIC HETEROZYGOTES WITH LDL-C >= 160 MG/DL AND DOCUMENTED CORONARY HEART 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