BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Incontinence, Mechanical/Hydraulic

    PMA: P000053 · Supplement: S040 · Decision Mar 9, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Device, Incontinence, Mechanical/Hydraulic
    Trade Name
    AMS 800 ARTIFICIAL URINARY SPHINCTER
    PMA Number
    P000053
    Supplement Number
    S040
    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
    March 9, 2012
    Date Received
    January 18, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MINOR CHANGES TO SEVERAL DIMENSIONAL TOLERANCES OF THE BALLOON ADAPTOR SUBCOMPONENT.

    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