BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Photopheresis, Extracorporeal

    PMA: P860003 · Supplement: S040 · Decision Apr 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    System, Photopheresis, Extracorporeal
    Trade Name
    UVAR XTS PHOTOPHERESIS SYSTEM
    PMA Number
    P860003
    Supplement Number
    S040
    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
    April 12, 2002
    Date Received
    March 15, 2002
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A LABELING CHANGE (INCLUSION OF AN ADDITIONAL WARNING) TO ADDRESS THE POTENTIAL FOR THE DEVELOPMENT OF HYPOVOLEMIA AND HYPOTENSION DURING PHOTOPHERESIS TREATMENTS IN PATIENTS WITH ELEVATED TRIGLYCERIDE LEVELS (HYPERLIPIDEMIA), SUCH AS PATIENTS RECEIVING CERTAIN CUTANEOUS T-CELL LYMPHOMA DRUGS, LIKE TARGRETIN. (BEXAROTENE).

    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