BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Incontinence, Mechanical/Hydraulic

    PMA: P000053 · Supplement: S056 · Decision Feb 4, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Device, Incontinence, Mechanical/Hydraulic
    Trade Name
    AMS 800 URINARY CONTROL SYSTEM (AUS)
    PMA Number
    P000053
    Supplement Number
    S056
    Device Class
    FDA Class 3
    Product Code
    EZY
    Generic Name
    Device, incontinence, mechanical/hydraulic
    Regulation Number
    876.5280
    Medical Specialty
    Gastroenterology, Urology
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 4, 2016
    Date Received
    February 27, 2015
    Supplement Type
    135 Review Track For 30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the implementation of a replacement injection mold, a contract molding service supplier change and a change to the outgassing process related to the collet component of the three devices.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EZY Device, Incontinence, Mechanical/Hydraulic