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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Agent, Bulking, Injectable For Gastro-Urology Use

    PMA: P900030 · Decision Sep 30, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Agent, Bulking, Injectable For Gastro-Urology Use
    Trade Name
    CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT
    PMA Number
    P900030
    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    Approved (Withdrawn)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
    September 30, 1993
    Date Received
    April 27, 1990
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Contigen™ Bard® Collagen Implant. This device is indicated for use in the treatment of urinary incontinence due to intrinsic sphincter deficiency (poor or non-functioning bladder outlet mechanism) that may be helped by a locally injected bulking agent. Contigen implant therapy is intended only for patients who have shown no improvement in their incontinence for at least 12 months.

    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