BEUDAMED
    Product Code: EZW FDA class 3 21 CFR 876.5270

    Stimulator, Electrical, Implantable, For Incontinence

    Gastroenterology, Urology

    The Implantable Electrical Stimulator for Incontinence (product code EZW) is a surgically implanted device that delivers electrical impulses to nerves or muscles of the lower urinary tract to treat urinary incontinence. It is classified as FDA Class 3 (highest risk), requiring Premarket Approval (PMA); PMAs were required to be filed by December 26, 1996 (61 FR 50707). It is regulated under 21 CFR 876.5270 in the Gastroenterology and Urology specialty. This device is designated as an implant.

    View on FDA
    510(k)s
    0
    FEI Numbers
    22
    Registration Numbers
    22
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    EZW
    Device Class
    FDA class 3
    Regulation Number
    876.5270
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    2

    Device Characteristics

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

    Definition

    PMAs to be filed by 12/26/96 (61 FR 50707 (9/27/96))

    FEI Numbers

    This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.