BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

    PMA: P960020 · Decision Aug 16, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Transurethral Occlusion Insert, Urinary Incontinence-Control, Female
    Trade Name
    RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE
    PMA Number
    P960020
    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
    Decision Code
    APPR
    Decision Date
    August 16, 1996
    Date Received
    August 18, 1995
    Expedited Review
    Y
    Docket Number
    96M-0447

    Advisory Committee Statement

    APPROVAL FOR THE RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE

    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