BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Agent, Bulking, Injectable For Gastro-Urology Use

    PMA: P030030 · Decision Dec 16, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Agent, Bulking, Injectable For Gastro-Urology Use
    Trade Name
    URYX URETHRAL BULKING AGENT
    PMA Number
    P030030
    Device Class
    FDA Class 3
    Product Code
    LNM
    Generic Name
    AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    December 16, 2004
    Date Received
    June 23, 2003
    Expedited Review
    N
    Docket Number
    05M-0089

    Advisory Committee Statement

    APPROVAL FOR THE URYX URETHRAL BULKING AGENT (URYX). THE DEVICE IS INDICATED FOR TRANSURETHRAL INJECTION IN THE TREATMENT OF ADULT WOMEN DIAGNOSED WITH STRESS URINARY INCONTINENCE (SUI) DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD).

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LNM Agent, Bulking, Injectable For Gastro-Urology Use