BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lipoprotein, Low Density, Removal

    PMA: P940016 · Supplement: S009 · Decision Sep 20, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Lipoprotein, Low Density, Removal
    Trade Name
    B.BRAUN,S HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P) SYSTEM
    PMA Number
    P940016
    Supplement Number
    S009
    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
    September 20, 2002
    Date Received
    June 7, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) THE TRANSFER OF THE STERILIZATION PROCESS FOR THE BLOOD TUBING LINE COMPONENT OF B. BRAUN MEDICAL, INC.'S HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM FROM ITS CURRENT, PMA APPROVED LOCATION TO THE B. BRAUN CAREX S.P.A. FACILITY; AND 2) THE PROPOSAL TO STERILIZE THE BLOOD TUBING LINES USING 10 PERCENT ETHYLENE OXIDE (ETO) AND 90 PERCENT CARBON DIOXIDE (CO2).

    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