BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Incontinence, Mechanical/Hydraulic

    PMA: P000053 · Supplement: S041 · Decision Aug 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Device, Incontinence, Mechanical/Hydraulic
    Trade Name
    AMS SPHINCTER 800 URINARY PROSTHESIS
    PMA Number
    P000053
    Supplement Number
    S041
    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
    August 21, 2012
    Date Received
    March 7, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REVISION OF THE AMOUNT OF RIFAMPIN AND MINOCYCLINE SPECIFIED IN THE INSTRUCTION FOR USE AND THE OPERATING ROOM MANUAL.

    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