BEUDAMED
    Product Code: LNM FDA class 3

    Agent, Bulking, Injectable For Gastro-Urology Use

    Unknown

    Agent, Bulking, Injectable for Gastro-Urology Use is an injectable material used to augment periurethral or submucosal tissue volume in the urethra or at the gastroesophageal junction, used in the treatment of stress urinary incontinence or gastroesophageal reflux disease by mechanically improving sphincter competence. This is an FDA Class 3 device, the highest risk category, requiring Premarket Approval (PMA) to demonstrate safety and effectiveness. The product code is LNM; no regulation number has been assigned, and the review panel is Gastroenterology/Urology. No special flags apply to this device.

    View on FDA
    510(k)s
    0
    FEI Numbers
    16
    Registration Numbers
    16
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    LNM
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    GU
    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 16 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.