BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implanted Fecal Incontinence Device

    PMA: P010020 · Supplement: S019 · Decision Dec 16, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Implanted Fecal Incontinence Device
    Trade Name
    ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER
    PMA Number
    P010020
    Supplement Number
    S019
    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
    December 16, 2010
    Date Received
    November 18, 2010
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A WARNING STATEMENT IN THE IFU PERTAINING TO THE APPROPRIATE CLEANING METHOD OF REUSABLE TOOLS USED IN THE ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER.

    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