BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Agent, Bulking, Injectable For Gastro-Urology Use

    PMA: P900030 · Supplement: S005 · Decision Mar 8, 1996
    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
    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
    March 8, 1996
    Date Received
    November 1, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR:1) MARKETINGTHE CURRENT CONTIGEN IMPLANT PRODUCT LINE IN A MODIFIED PACKAGING CONFIGURATION INSTEAD OF THE CURRENT CONFIGURATION, 2)CHANGING THE LOCATION OF THE SKINT TEST PACKAGING OPERATIN FROM COLLAGEN CORP, FREMONT, CA, TO BARD UROLOGICAL DIV, COVINGTON, GA 3)REVISING THE WARNING STATEMENT REGARDING CONNECTIVE TISSUE DISEASE IN THE PACKAGE INSERTS, PATIENT BROCHURES AND SAFETY SUMMARIES, AND 4)UPDATING THE PATIENT RECORD AND SKIN TEST CARD LABELING

    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