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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 Namefluorescence imaging system
PMA NumberP950042
Supplement NumberS001
Date Received04/30/1998
Decision Date07/21/1998
Product Code
MRK[ Registered Establishments with MRK ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason pas protocal supplement ode/oir
Expedited Review Granted? No
Combination Product No
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.