BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Incontinence, Mechanical/Hydraulic

    PMA: P000053 · Supplement: S047 · Decision Feb 6, 2013
    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 (AUS)
    PMA Number
    P000053
    Supplement Number
    S047
    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 6, 2013
    Date Received
    November 6, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE LABELING CHANGE FROM 1.5 TESLA (1.5T) MAGNETICRESONANCE IMAGING (MRI) STRENGTH LEVEL TO 3.0 TESLA (3.0T) FOR THE BUNDLED AMS PRODUCTS. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES: 1) AMS 700 AND AMBICOR INFLATABLE PENILE PROSTHESIS (IPP) ARE INTENDED FOR USE IN THE TREATMENT OF CHRONIC, ORGANIC, MALE ERECTILE DYSFUNCTION (IMPOTENCE); 2) AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS) TREATS URINARY INCONTINENCE DUE TOREDUCED OUTLET RESISTANCE (INTRINSIC SPHINCTER DEFICIENCY) FOLLOWING PROSTATE SURGERY; AND 3) AMS ACTICON NEOSPHINCTER, ARTIFICIAL BOWEL SPHINCTER (ABS) IS TO TREAT SEVERE FECAL INCONTINENCE IN MALES AND FEMALES EIGHTEEN YEARS AND OLDER WHO HAVE FAILED, OR ARE NOTCANDIDATES FOR, LESS INVASIVE FORMS OF RESTORATIVE THERAPY.

    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