BEUDAMED
    FDA PMA FDA Unclassified Approved 🇺🇸 United States

    Separator, Automated, Blood Cell And Plasma, Therapeutic

    PMA: P850020 · Supplement: S011 · Decision Mar 15, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Separator, Automated, Blood Cell And Plasma, Therapeutic
    Trade Name
    PROSORBA(TM) COLUMN
    PMA Number
    P850020
    Supplement Number
    S011
    Device Class
    FDA Unclassified
    Product Code
    LKN
    Generic Name
    Separator, automated, blood cell and plasma, therapeutic
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 15, 1999
    Date Received
    July 21, 1998
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    99M-0871

    Advisory Committee Statement

    Approval for the Prosorba(R) Column. This device is indicated for: 1) use in the therapeutic removal of immunoglobulin G (IgG) and IgG-containting circulating immune complexes from plasma in patients with idiopathic thrombocytopenic purpura (ITP) having platelet counts less than 100,000mm3 and 2) for use in the therapeutic reduction of the signs and symptoms of moderate to severe rheumatoid arthritis (RA) in adult patients with long-standing disease who have failed or are intolerant to disease-modifying anti-rheumatic drugs (DMARDs).

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LKN Separator, Automated, Blood Cell And Plasma, Therapeutic