BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Optune Lua

    Reg #: 3009306483 · FEI: 3009306483 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NOVOCURE INC
    Registration Number
    3009306483
    FEI Number
    3009306483
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    195 Commerce Way
    City
    Portsmouth
    State
    NH
    ZIP
    03801
    Country
    US

    Regulatory Submissions

    PMA Number
    P230042

    Owner / Operator

    Firm Name
    NOVOCURE INC
    Operator Number
    10040460
    Address
    195 Commerce Way
    City
    Portsmouth
    State
    NH
    Postal Code
    03801
    Country
    US
    Correspondent
    Lori A Burns

    Products

    Device Name Product Code
    Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer SDA

    Proprietary Names

    Optune Lua

    Establishment Types

    Manufacture Medical Device