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

    System, Photopheresis, Extracorporeal

    PMA: P860003 · Supplement: S106 · Decision Mar 11, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    System, Photopheresis, Extracorporeal
    Trade Name
    THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAKO
    PMA Number
    P860003
    Supplement Number
    S106
    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
    March 11, 2022
    Date Received
    February 9, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Moving the moulding production of the Y-Fitting Adapter component from Harmac Buffalo, NY, USA site to Harmac Castlerea, Republic of Ireland site to improve moulding capacity and component supply.

    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