BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lipoprotein, Low Density, Removal

    PMA: P940016 · Supplement: S001 · Decision Apr 26, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Lipoprotein, Low Density, Removal
    Trade Name
    HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM
    PMA Number
    P940016
    Supplement Number
    S001
    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 26, 1999
    Date Received
    November 2, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    N

    Advisory Committee Statement

    Approval for a change in the potting resin material (i.e., from polypropylene Valtech (Montell) HH-44 to polypropylene Pro-Fax PH920S) used to seal the end caps of the H.E.L.P. System Precipitate Filter.

    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