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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA
Generic NameSYSTEM, IMAGING, FLUORESCENCE
ApplicantNOVADAQ TECHNOLOGIES, INC.
2585 SKYMARK AVENUE, STE. 306
MISSISSAUGA, ONTARIO L4W 4
PMA NumberP950042
Date Received12/22/1995
Decision Date09/19/1996
Product Code MRK 
Docket Number 97M-0122
Notice Date 04/01/1997
Advisory Committee Ear Nose & Throat
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE XILLIX LIFE-LUNG FLUORESCENCE ENDOSCOPY SYSTEM
Supplements:  S001 S003 S004 S007 
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