BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Photopheresis, Extracorporeal

    PMA: P860003 · Supplement: S093 · Decision Jan 28, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    System, Photopheresis, Extracorporeal
    Trade Name
    Therakos Cellex Photopheresis System
    PMA Number
    P860003
    Supplement Number
    S093
    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
    January 28, 2018
    Date Received
    July 10, 2017
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for manufacturing site located at Harmac Medical Products Limited , I.D.A Industrial EstateCastlerea Roscommon, Ireland for the manufacture and finished product release testing for CELLEX Procedural Kits ; Synergy Health Ireland Ltd , IDA Industrial Estate , Tullamore, Offaly, Ireleand for the sterilization of CELLEX Procedural Kits; and Synergy Health (Steris), Thorne, UK Ltd , Alpha Court Capitol Park, Thorne, South Yorkshire DN8 5TZ, United Kingdom, as the alternate sterilization location for the CELLEX Procedural 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