BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    System, Photopheresis, Extracorporeal

    PMA: P860003 · Supplement: S034 · Decision Nov 29, 1999
    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
    S034
    Device Class
    FDA Class 3
    Product Code
    LNR
    Generic Name
    System, photopheresis, extracorporeal
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 29, 1999
    Date Received
    November 5, 1999
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    The 30-Day Notice requested a change in the sterilization process to place the biological indicator, that is normally placed inside of the treatment kit packaging, in an external challenge device on the outside of the kits.

    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