BEUDAMED
    Product Code: MBX FDA class 3

    Stimulator, Thalamic, Epilepsy, Implanted

    Unknown

    The implanted thalamic stimulator for epilepsy is a surgically placed neurostimulation device designed to deliver electrical stimulation to the thalamus to reduce seizure frequency or severity in patients with refractory epilepsy. It is classified as FDA Class III, requiring Premarket Approval (PMA) with rigorous clinical evidence of safety and effectiveness. The product code is MBX and no regulation number or formal medical specialty has been assigned. The device carries an implant flag reflecting its surgical placement within the brain.

    View on FDA
    510(k)s
    0
    FEI Numbers
    12
    Registration Numbers
    12
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MBX
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    NE
    Submission Type
    3

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.