BEUDAMED
    Product Code: LGW FDA class 3

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    Unknown

    A totally implanted spinal cord stimulator for pain relief is a surgically implanted neurostimulation system that delivers electrical impulses to the spinal cord to modulate pain signals, used in patients with chronic intractable pain conditions such as failed back surgery syndrome or complex regional pain syndrome. The device is FDA Class 3, the highest risk category, requiring Pre-Market Approval (PMA) to demonstrate safety and effectiveness before marketing. It carries product code LGW and no specific 21 CFR regulation number or medical specialty is recorded. This device is flagged as an implant, as it is surgically placed within the body.

    View on FDA
    510(k)s
    0
    FEI Numbers
    56
    Registration Numbers
    56
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    LGW
    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

    FEI Numbers

    This FDA classification entry is associated with 56 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 56 registration numbers. Click on an entry to view related FDA registrations.