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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 NumberS013
Date Received03/20/2009
Decision Date04/09/2009
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an updated version of the copilot health management system for freestyle navigator labeling and help files in the application to add windows vista as an operating system that the application can be installed on as well as adding the necessary steps to allow the application and device to be used with vista.
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