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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 CYLINDRICAL FIBER OPTIC
Classification Namesystem, laser, fiber optic, photodynamic therapy
Generic Namelaser for photodynamic therapy (pdt)
ApplicantQLT PHOTOTHERAPEUTICS, INC.
PMA NumberP940010
Supplement NumberS007
Date Received07/08/1999
Decision Date08/13/1999
Product Code
MVG[ Registered Establishments with MVG ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revision ot the package labeling and package insert labeling. The approved modifications include clarification of directions for use and device descriptions and simplification of use of trademark or registered trademark symbols.
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