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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.
 
Trade Name600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS
Generic Namelaser for photodynamic therapy
ApplicantLASERSCOPE
PMA NumberP940012
Supplement NumberS001
Date Received02/11/1997
Decision Date01/09/1998
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
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 patients for whom surgery and radiotherapy are not indicated.
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