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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 CONTINUOUS GLUCOSE MONITORING SYSTEM
Classification Namesensor, glucose, invasive
Generic Namecontinuous glucose monitor
ApplicantABBOTT LABORATORIES
PMA NumberP050020
Supplement NumberS021
Date Received12/22/2009
Decision Date01/11/2010
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes for the freestyle navigator user¿s guide as follows: 1) addition of the statement under the ¿specifications¿ section¿ ¿store the test strips between 40 degrees f and 86 degrees f. ¿; 2) addition of the statement under the ¿important notes¿ section: ¿the system is intended for your personal use; do not share your system with others. ¿.
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