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

    System, Photopheresis, Extracorporeal

    PMA: P860003 · Supplement: S082 · Decision Jan 21, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    System, Photopheresis, Extracorporeal
    Trade Name
    THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT
    PMA Number
    P860003
    Supplement Number
    S082
    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
    January 21, 2016
    Date Received
    December 24, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    A CHANGE IN THE INSPECTION PROCESS FOR CELLEX PROCEDURAL KIT CARTONS PRIOR TO THEIR PLACEMENT IN THEIR SHIPPING PALLETS.

    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