BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implanted Fecal Incontinence Device

    PMA: P010020 · Supplement: S006 · Decision Apr 16, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Implanted Fecal Incontinence Device
    Trade Name
    ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPHINCTER
    PMA Number
    P010020
    Supplement Number
    S006
    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
    April 16, 2008
    Date Received
    July 2, 2007
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE RELEASE AGENT USED IN THE DISPERSION PROCESS.

    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