BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lipoprotein, Low Density, Removal

    PMA: P940016 · Supplement: S012 · Decision Apr 20, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Lipoprotein, Low Density, Removal
    Trade Name
    PLASMAT SECURA HEPARIN-INDUCED EXTRACORPOREAL LDL APHERESIS SYSTEM (H.E.L.P.)
    PMA Number
    P940016
    Supplement Number
    S012
    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
    April 20, 2009
    Date Received
    February 19, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE PACKAGING MATERIAL IN THE POUCH USED FOR THE HEPARIN ADSORBER COMPONENT OF THE DEVICE.

    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