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U.S. Department of Health and Human Services

Devices@FDA
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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.
 
DeviceFREESTYLE NAVIGATOR CONTIUOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantAbbott Laboratories
1360 S. Loop Rd.
Alameda, CA 94502
PMA NumberP050020
Supplement NumberS013
Date Received03/20/2009
Decision Date04/09/2009
Withdrawal Date03/18/2013
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
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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