BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lipoprotein, Low Density, Removal

    PMA: P910018 · Supplement: S037 · Decision Mar 5, 2025
    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
    Supplement Number
    S037
    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
    March 5, 2025
    Date Received
    July 26, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of the above referenced premarket approval application (PMA) 180-day supplement(s)/75-day humanitarian device exemption (HDE) supplement(s), which requested approval for packaging material (the shape of the cap, removing one material (styrene elastomer) from the cap, and the welding of the cap to the device), labeling, and a new sterilization site at Kaneka Corporation Tomatoh Plant Tomakomai, Hokkaido, 059-1362 Japan.

    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