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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 NamePINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA
Classification Namesystem, imaging, fluorescence
Generic Namefluorescence imaging system
ApplicantNOVADAQ TECHNOLOGIES, INC.
PMA NumberP950042
Supplement NumberS007
Date Received12/01/2011
Decision Date02/02/2012
Product Code
MRK[ Registered Establishments with MRK ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the trade name of the medical device from pinpoint to onco-life endoscopic light source and video camera.
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