BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Implanted Fecal Incontinence Device

    PMA: P010020 · Supplement: S031 · Decision Apr 15, 2015
    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
    Supplement Number
    S031
    Device Class
    FDA Class 3
    Product Code
    MIP
    Generic Name
    Implanted fecal incontinence device
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 15, 2015
    Date Received
    March 16, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    MINOR CHANGES TO THE FILTER PRESS FIXTURE USED IN THE MANUFACTURE OF THE AMS 700 IPP, AMBICOR, AMS 800 AUS, AND ACTICON NEOSPHINCTER DEVICES.

    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