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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.
Classification Namesystem, imaging, fluorescence
Generic Namesystem, imaging, fluorescence
2585 skymark avenue, ste. 306
mississauga, ontario L4W 4
PMA NumberP950042
Supplement NumberS003
Date Received09/30/2004
Decision Date06/30/2005
Product Code
MRK[ Registered Establishments with MRK ]
Docket Number 05M-0284
Notice Date 07/18/2005
Advisory Committee Ear Nose & Throat
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the onco-life endoscopic light source and video camera (onco-life). This device is indicated for use with fluorescence imaging during bronchoscopy as an adjunct to white light imaging, to detect and localize tissue suspicious for moderate or severe dysplasia, carcinoma in situ, or invasive cancer in patients with suspected or previously treated lung cancer.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling