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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 CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantAbbott Laboratories
1360 S. Loop Rd.
Alameda, CA 94502
PMA NumberP050020
Supplement NumberS021
Date Received12/22/2009
Decision Date01/11/2010
Withdrawal Date03/18/2013
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
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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