BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Photopheresis, Extracorporeal

    PMA: P860003 · Supplement: S048 · Decision Mar 20, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    System, Photopheresis, Extracorporeal
    Trade Name
    UVAR CELLEX PHOTOPHERESIS SYSTEM
    PMA Number
    P860003
    Supplement Number
    S048
    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
    March 20, 2009
    Date Received
    June 11, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ENGINEERING AND DESIGN CHANGES TO THE UVAR XTSPHOTOPHERESIS SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMETHERAKOS CELLEX PHOTOPHERESIS SYSTEM, AND IS INDICATED FOR USE IN THE ULTRAVIOLET-A(UVA) IRRADIATION, IN THE PRESENCE OF THE PHOTOACTIVE DRUG 8-METHOXYPSORALEN (8-MOP), OFEXTRACORPOREALLY CIRCULATING LEUKOCYTE-ENRICHED BLOOD, IN THE PALLIATIVE TREATMENT OF THE SKINMANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA (CTCL), IN PERSONS WHO HAVE NOT BEEN RESPONSIVE TO OTHER FORMS OF TREATMENT.

    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