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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceXILLIX-LIFE-LUNG
Generic NameSYSTEM, IMAGING, FLUORESCENCE
ApplicantNovadaq Technologies, Inc.
2585 Skymark Ave., Suite 306
Mississauga, Ontario L4W 4L5
PMA NumberP950042
Supplement NumberS001
Date Received04/30/1998
Decision Date07/21/1998
Product Code MRK 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to amend the post-market study. A third investigator will be added to assist in collecting sets of images whichwill be used to produce the "test set" of images for the reproducibility testing.
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