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

    Implanted Fecal Incontinence Device

    PMA: P010020 · Supplement: S026 · Decision Oct 5, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Implanted Fecal Incontinence Device
    Trade Name
    AMS ACTICON NEOPHINCTER
    PMA Number
    P010020
    Supplement Number
    S026
    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
    October 5, 2012
    Date Received
    September 10, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    THE SILICON RECEIVING INSPECTION AND MILLING PROCESSES TO BE STREAMLINED AND TO REMOVE DUPLICATE TESTING TO PROVIDE CONSISTENCY FOR THE ENTIRE SILICONE PROCESSES.

    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