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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 NameOPTIGUIDE(TM) FIBER OPTIC DIFFUSER
Classification Namesystem, laser, fiber optic, photodynamic therapy
Generic Namelaser for photodynamic therapy (pdt)
ApplicantQLT PHOTOTHERAPEUTICS, INC.
PMA NumberP940010
Supplement NumberS002
Date Received02/10/1997
Decision Date01/09/1998
Product Code
MVG[ Registered Establishments with MVG ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
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 and approval to add a 2. 0 cm diffuser to the dcyl series of diffusers.
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