BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P970015 · Supplement: S002 · Decision May 14, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    NOVUS TM LC THREADED INTERBODY FUSION DEVICE (TIBFD)
    PMA Number
    P970015
    Supplement Number
    S002
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 14, 1999
    Date Received
    September 9, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Supplement received prior to original approval. Supplement approved as part of the original approval order.