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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 may have changed. Be sure to look at the supplements 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
Date Received12/22/1995
Decision Date09/19/1996
Product Code
MRK[ Registered Establishments with MRK ]
Docket Number 97M-0122
Notice Date 04/01/1997
Advisory Committee Ear Nose & Throat
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the xillix life-lung fluorescence endoscopy system.
Supplements: S001 S003 S004 S007 
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