BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implanted Fecal Incontinence Device

    PMA: P010020 · Supplement: S024 · Decision Sep 4, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Implanted Fecal Incontinence Device
    Trade Name
    ACTICON NEOSPHINCTER
    PMA Number
    P010020
    Supplement Number
    S024
    Device Class
    FDA Class 3
    Product Code
    MIP
    Generic Name
    Implanted fecal incontinence device
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 4, 2012
    Date Received
    June 27, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE DESIGN SPECIFICATIONS AND MANUFACTURING PROCESS OF THE AMS ACTICON CONTROL PUMP, A COMPONENT OF THE AMS ACTICON NEOSPHINCTER.

    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