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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.
 
DevicePINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA
Classification Namesystem, imaging, fluorescence
Generic Namesystem, imaging, fluorescence
Applicant
NOVADAQ TECHNOLOGIES, INC.
2585 skymark avenue, ste. 306
mississauga, ontario L4W 4
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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