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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 NumberS011
Date Received02/23/2009
Decision Date04/13/2009
Withdrawal Date03/18/2013
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A STERILIZATION SITE LOCATED AT NUTEK CORPORATION, HAYWARD, CALIFORNIA, TO PERFORM STERILIZATION OF THE SENSOR DELIVERY UNIT.
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