BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Device, Incontinence, Mechanical/Hydraulic

    PMA: P000053 · Supplement: S140 · Decision Jul 14, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Device, Incontinence, Mechanical/Hydraulic
    Trade Name
    AMS 800 Artificial Urinary Sphincter (AUS)
    PMA Number
    P000053
    Supplement Number
    S140
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 14, 2025
    Date Received
    June 17, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    changes to update manufacturing instructions to ensure proper component seating prior to tray sealing and updates to the visual packaging inspection process

    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