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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCOHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS
ApplicantLumenis, Inc.
3959 W. 1820 S.
Salt Lake City, UT 84104
PMA NumberP940011
Supplement NumberS001
Date Received02/14/1997
Decision Date01/09/1998
Withdrawal Date01/14/2014
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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