|
Device | COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS |
Applicant | LUMENIS, INC. 3959 WEST 1820 SOUTH SALT LAKE CITY, UT 84104 |
PMA Number | P940011 |
Supplement Number | S001 |
Date Received | 02/14/1997 |
Decision Date | 01/09/1998 |
Withdrawal Date
|
01/14/2014 |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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. |