BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Low Electric Field Generator For Pancreatic Cancer Treatment

    PMA: P250034 · Decision Feb 11, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Low Electric Field Generator For Pancreatic Cancer Treatment
    Trade Name
    Optune Pax
    PMA Number
    P250034
    Device Class
    FDA Class 3
    Product Code
    SHC
    Generic Name
    Low Electric Field Generator for Pancreatic Cancer Treatment
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 11, 2026
    Date Received
    August 15, 2025
    Expedited Review
    N
    Docket Number
    FDA-1893

    Advisory Committee Statement

    Optune Pax is intended for treatment of adult patients with locally advanced pancreatic cancer, concomitant with gemcitabine and nab-paclitaxel.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SHC Low Electric Field Generator For Pancreatic Cancer Treatment