BEUDAMED
    Product Code: PMP FDA class 3

    Dorsal Root Ganglion Stimulator For Pain Relief

    Unknown

    The Dorsal Root Ganglion Stimulator For Pain Relief (product code PMP) is a Class 3 device intended for stimulation of the dorsal root ganglion to treat chronic, intractable pain of the lower limbs. Class 3 devices require Premarket Approval (PMA), the most rigorous FDA pathway, reflecting the higher risk of implantable neurostimulation devices. The device is flagged as an implant and has no regulation number or formal medical specialty designation assigned.

    View on FDA
    510(k)s
    0
    FEI Numbers
    9
    Registration Numbers
    9
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    PMP
    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

    Stimulation of the dorsal root ganglion for the treatment of chronic, intractable pain of the lower limbs.

    FEI Numbers

    This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.