BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Incontinence, Mechanical/Hydraulic

    PMA: P000053 · Supplement: S053 · Decision Jan 28, 2015
    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
    S053
    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
    January 28, 2015
    Date Received
    November 3, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE USE OF (I) THE ZONE OF INHIBITION (ZOI) AS THE SHELF LIFE INDICATION FACTOR AND TO CONSISTENTLY USE (II) A TWO YEAR SHELF LIFE FOR INHIBIZONE® (IZ) TREATED DEVICES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AMS 800 ARTIFICIAL URINARY SPHINCTER (AMS 800). THE DEVICE IS USED TO TREAT URINARY INCONTINENCE DUE TO REDUCED OUTLET RESISTANCE (INTRINSIC SPHINCTER DEFICIENCY) FOLLOWING PROSTATE SURGERY. THE AMS 700 INFLATABLE PENILE PROSTHESIS (AMS 700) IS USED IN THE TREATMENT OF CHRONIC, MALE ERECTILE DYSFUNCTION (IMPOTENCE).

    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