BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Bulking, Injectable For Gastro-Urology Use

    PMA: P030030 · Supplement: S005 · Decision Feb 16, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Agent, Bulking, Injectable For Gastro-Urology Use
    Trade Name
    BARD TEGRESS URETHRAL IMPLANT
    PMA Number
    P030030
    Supplement Number
    S005
    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
    Decision Code
    APPR
    Decision Date
    February 16, 2007
    Date Received
    February 2, 2007
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE TEGRESS URETHRAL IMPLANT INSTRUCTIONS FOR USE AND PATIENT INFORMATION BROCHURE TO MINIMIZE THE INCIDENCE OF ADVERSE EVENTS (E.G., EROSION AND NECROSIS) AND ENHANCE THE SAFETY OF DEVICE USE.

    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