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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceCOHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS
Applicant
LUMENIS, INC.
3959 west 1820 south
salt lake city, UT 84104
PMA NumberP940011
Supplement NumberS001
Date Received02/14/1997
Decision Date01/09/1998
Advisory Committee General & Plastic Surgery
Supplement Typenormal 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.
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