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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.
 
Trade NameFREESTYLE NAVIGATOR CONTIUOUS GLUCOSE MONITORING SYSTEM
Classification Namesensor, glucose, invasive
Generic Namecontinuous glucose monitor
ApplicantABBOTT LABORATORIES
PMA NumberP050020
Supplement NumberS008
Date Received11/28/2008
Decision Date10/29/2009
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the freestyle navigator continuous glucose monitoring system receiver software. The primary purpose of the new software is to allow users to obtain continuous glucose data as quickly as possible after insertion of the sensor. The new algorithm changes the calibration time to 1, 2, 10, 24 and 72 hours, with glucose data being available at one hour. Other changes are the increase to allowable range for glucose calibration, increase to the allowable glucose rate change and the addition of a calibration lag correction. Additional changes were made to the receiver software/user interface; the backlight will now always be on when the receiver is displaying information, the screen timeout will be 20 seconds and there will be no abandon alarm feature.
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