BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lipoprotein, Low Density, Removal

    PMA: P910018 · Decision Feb 21, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Lipoprotein, Low Density, Removal
    Trade Name
    LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).
    PMA Number
    P910018
    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 21, 1996
    Date Received
    March 26, 1991
    Expedited Review
    N
    Docket Number
    96M-0193

    Advisory Committee Statement

    APPROVAL FOR THE LIPOSORBER LA-15 SYSTEM. THE DEVICE IS A LOW DENSITY LIPOPROTEIN (LDL) APHERESIS SYTEM

    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