BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P940011 · Supplement: S001 · Decision Jan 9, 1998
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS
    PMA Number
    P940011
    Supplement Number
    S001
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 9, 1998
    Date Received
    February 14, 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 in patients for whom surgery and radiotherapy are not indicated.