BEUDAMED
    FDA PMA FDA Unclassified Approved 🇺🇸 United States

    Separator, Automated, Blood Cell And Plasma, Therapeutic

    PMA: P850020 · Supplement: S017 · Decision Apr 15, 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
    S017
    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 15, 2004
    Date Received
    April 15, 2003
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING CHANGES TO 1) ADD A PRECAUTION ABOUT THE USE OF PEDIATRIC ASPIRIN FOR RHEUMATOID ARTHRITIS (RA) PATIENTS DUE TO THE INCREASES RISK OF THROMBOSIS, AND 2) SPECIFY THE TREATMENT REGIMEN FOR IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP) PATIENTS SO THAT PATIENTS RECEIVE 6 TREATMENTS, 2-3 TIMES A WEEK FOR 2 OR 3 WEEKS.

    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