BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Bulking, Injectable For Gastro-Urology Use

    PMA: P900030 · Supplement: S011 · Decision Oct 2, 2009
    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 BARD COLLAGEN IMPLANT
    PMA Number
    P900030
    Supplement Number
    S011
    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
    October 2, 2009
    Date Received
    March 3, 2009
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REVISED DIRECTIONS FOR USE (DFU) THAT INCLUDES INFORMATION FROM THE POST-APPROVAL STUDY ON COHORT C. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CONTIGEN BARD COLLAGEN IMPLANT AND IS INDICATED FOR USE ONLY IN THE TREATMENT OF URINARY INCONTINENCE DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD, POOR OR NONFUNCTIONING BLADDER OUTLET MECHANISM) THAT MAY BE HELPED BY A LOCALLY INJECTED BULKING AGENT. CONTIGEN IMPLANT THERAPY SHOULD BE INITIATED ONLY IN 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