BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Photopheresis, Extracorporeal

    PMA: P860003 · Supplement: S111 · Decision Feb 27, 2025
    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), THERAK
    PMA Number
    P860003
    Supplement Number
    S111
    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
    February 27, 2025
    Date Received
    December 12, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for software and labelling changes proposed for the TherakosCellex Photopheresis System to provide adequate instruction and controls for the use of a new anticoagulant (ACD-A) with the Cellex Photopheresis system and change to the materials of the Therakos Cellex Photopheresis procedural kit to remove the plasticizer di(2-ethylhexyl) phthalate, more commonly known as DEHP.

    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