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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 Nameinstrument, glucose, noninvasive technology
Generic Nameinstrument, glucose, noninvasive technology\
ApplicantCYGNUS, INC.
PMA NumberP990026
Supplement NumberS018
Date Received07/01/2003
Decision Date11/20/2003
Product Code
NCT[ Registered Establishments with NCT ]
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the signal processing routine and data point screening parameters of the biographer to reduce the number of skipped readings, modifications to the down alert of the biographer to increase the specificity of the alarm feature and an autosensor formulation change to improve the biographer calibration.