BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P940012 · Supplement: S001 · Decision Jan 9, 1998
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS
    PMA Number
    P940012
    Supplement Number
    S001
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 9, 1998
    Date Received
    February 11, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the additional indication for use for the treatment of microinvasive endobronchial nonsmall cell lung cancer patients for whom surgery and radiotherapy are not indicated.