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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Implanted Fecal Incontinence Device

    PMA: P010020 · Decision Dec 18, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Implanted Fecal Incontinence Device
    Trade Name
    AMS ACTICON NEOSPHINCTER
    PMA Number
    P010020
    Device Class
    FDA Class 3
    Product Code
    MIP
    Generic Name
    Implanted fecal incontinence device
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    December 18, 2001
    Date Received
    March 30, 2001
    Expedited Review
    N
    Docket Number
    01M-0581

    Advisory Committee Statement

    APPROVAL FOR THE AMS ACTICON NEOSPHINCTER SYSTEM. THIS DEVICE IS INDICATED TO TREAT SEVERE FECAL INCONTINENCE IN MALES AND FEMALES EIGHTEEN YEARS AND OLDER WHO HAVE FAILED, OR ARE NOT CANDIDATES FOR, LESS INVASIVE FORMS OF RESTORATIVE THERAPY.

    Classifications

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

    Product Code Device Name
    MIP Implanted Fecal Incontinence Device