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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 NumberS003
Date Received02/18/1997
Decision Date04/04/1997
Product Code
MVG[ Registered Establishments with MVG ]
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 labeling changes associated with the introduction of a second distributor.
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