BEUDAMED
    FDA PMA FDA Unclassified Approved 🇺🇸 United States

    Separator, Automated, Blood Cell And Plasma, Therapeutic

    PMA: P850020 · Supplement: S020 · Decision Aug 17, 2005
    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 PROTEIN A IMMUNOADSORPTION COLUMN
    PMA Number
    P850020
    Supplement Number
    S020
    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
    August 17, 2005
    Date Received
    July 1, 2005
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ETHYLENE OXIDE (EO) STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, INC., WAUKEGAN, ILLINOIS.

    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