BEUDAMED
    Product Code: PJS FDA class 3

    Stimulator, Electrical, Implanted, For Essential Tremor

    Unknown

    The Implanted Electrical Stimulator for Essential Tremor is a deep brain stimulation (DBS) device used for the treatment of essential tremor through targeted electrical stimulation of specific brain nuclei. It is an FDA Class 3 device, requiring Pre-Market Approval (PMA) due to the high risk associated with implanted neurological devices, reviewed by the Neurology (NE) panel. The product code is PJS, and it is flagged as an implant. No regulation number or medical specialty has been formally assigned.

    View on FDA
    510(k)s
    0
    FEI Numbers
    28
    Registration Numbers
    28
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    PJS
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    NE
    Submission Type
    2

    Device Characteristics

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

    Definition

    Deep Brain Stimulation for the treatment of essential tremor

    FEI Numbers

    This FDA classification entry is associated with 28 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.