BEUDAMED
    FDA PMA FDA Unclassified Approved 🇺🇸 United States

    Separator, Automated, Blood Cell And Plasma, Therapeutic

    PMA: P850020 · Supplement: S019 · Decision Apr 14, 2004
    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 COLUMN
    PMA Number
    P850020
    Supplement Number
    S019
    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
    April 14, 2004
    Date Received
    October 17, 2003
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR SEVERAL CHANGES TO THE RA-4 POST-APPROVAL STUDY PROTOCOL. SPECIFICALLY, THESE ARE: 1) A CHANGE IN INCLUSION CRITERION 6 TO ALLOW THE ENROLLMENT OF PATIENTS WHO HAVE BEEN ON METHOTREXATE (>= 15 MG/WEEK) FOR AT LEAST THREE MONTHS PRIOR TO SCREENING, RATHER THAN SIX MONTHS PRIOR TO SCREENING; 2) THE ADDITION OF AN INCLUSION CRITERION TO ALLOW THE ENROLLMENT OF PATIENTS WHO HAVE HAD TOXICITY TO METHOTREXATE AT A DOSE OF >= 15 MG/WEEK IF THEY CAN BE ON A DOSE OF 12.5 MG/WEEK; 3) THE INCLUSION OF PATIENTS RECEIVING CONCOMITANT TREATMENT WITH OTHER DISEASE-MODIFYING ANTI-RHEUMATIC DRUGS (DMARDS); AND 4) THE INCLUSION OF PATIENTS WITH 12 OR MORE JOINTS TENDER OR PAINFUL ON MOTION OR PRESSURE, RATHER THAN 16 SUCH JOINTS.

    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