BEUDAMED
    Product Code: PFN FDA class 3

    Implanted Brain Stimulator For Epilepsy

    Unknown

    The Implanted Brain Stimulator for Epilepsy is a neurostimulation device designed to treat epilepsy through electrical stimulation delivered to targeted brain regions. It is an FDA Class 3 device, the highest risk classification, requiring Pre-Market Approval (PMA) due to the significant risks associated with implanted neurological devices. The product code is PFN, reviewed by the neurology (NE) panel, and no regulation number has been assigned. This device carries an implant flag, indicating surgical placement within the skull or brain tissue.

    View on FDA
    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    PFN
    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

    For the treatment of epilepsy.

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.