BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Photopheresis, Extracorporeal

    PMA: P860003 · Supplement: S037 · Decision Jan 5, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    System, Photopheresis, Extracorporeal
    Trade Name
    UVAR XTS(TM) PHOTOPHERESIS SYSTEM
    PMA Number
    P860003
    Supplement Number
    S037
    Device Class
    FDA Class 3
    Product Code
    LNR
    Generic Name
    System, photopheresis, extracorporeal
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 5, 2001
    Date Received
    July 7, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING SOFTWARE CHANGES: 1) REMOVAL OF SYSTEM ERROR F522:0000, 2) REMOVAL OF SYSTEM ERROR F581:0000, 3) CHANGE IN THE ALARM THRESHOLD FOR THE CENTRIFUGE BOWL VACUUM, AND 4) ADDITION OF NEW PRIMING STATE.

    Classifications

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

    Product Code Device Name
    LNR System, Photopheresis, Extracorporeal