BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Photopheresis, Extracorporeal

    PMA: P860003 · Supplement: S087 · Decision Apr 27, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    System, Photopheresis, Extracorporeal
    Trade Name
    THERAKOS CELLEX PHOTOPHERESIS SYSTEM, INSTRUMENT, LIGHT ASSEMBLY, PROCEDURAL KIT.
    PMA Number
    P860003
    Supplement Number
    S087
    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 27, 2017
    Date Received
    May 18, 2016
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes to the software, circuit board, drive tube bearing retainer, power supply, and labeling.

    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