BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

    PMA: P990002 · Decision Sep 30, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Transurethral Occlusion Insert, Urinary Incontinence-Control, Female
    Trade Name
    FEMSOFT URETHRAL INSERT
    PMA Number
    P990002
    Device Class
    FDA Class 3
    Product Code
    OCK
    Generic Name
    Transurethral occlusion insert, urinary incontinence-control, female
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    September 30, 1999
    Date Received
    January 19, 1999
    Expedited Review
    N
    Docket Number
    99M-4330

    Advisory Committee Statement

    The device is indicated for the management of stress urinary incontinence in adult females.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OCK Transurethral Occlusion Insert, Urinary Incontinence-Control, Female