BEUDAMED
    FDA PMA FDA Unclassified 30-Day Notice Accepted 🇺🇸 United States

    Separator, Automated, Blood Cell And Plasma, Therapeutic

    PMA: P850020 · Supplement: S015 · Decision May 15, 2002
    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
    S015
    Device Class
    FDA Unclassified
    Product Code
    LKN
    Generic Name
    Separator, automated, blood cell and plasma, therapeutic
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 15, 2002
    Date Received
    April 15, 2002
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    REDUCTION IN THE TIME OF THE REACTION STEP IN THE MANUFACTURING PROCESS AND A DECREASE IN THE AMOUNT OF CARBODIIMIDE USED IN THE PROCESS.

    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