BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Incontinence, Mechanical/Hydraulic

    PMA: P130018 · Decision Nov 24, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Device, Incontinence, Mechanical/Hydraulic
    Trade Name
    PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN
    PMA Number
    P130018
    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
    November 24, 2015
    Date Received
    June 17, 2013
    Expedited Review
    N
    Docket Number
    15M-4473

    Advisory Committee Statement

    APPROVAL FOR THE PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN. THIS DEVICE IS INDICATED FOR THE TREATMENT OF ADULT MEN WHO HAVE STRESS INCONTINENCE ARISING FROM INTRINSIC SPHINCTER DEFICIENCY OF AT LEAST TWELVE MONTHS DURATION FOLLOWING RADICAL PROSTATECTOMY OR TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) AND WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE 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