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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 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.
 
DeviceFRESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantAbbott Laboratories
1360 South Loop Road
Alameda, CA 94502
PMA NumberP050020
Supplement NumberS032
Date Received12/02/2010
Decision Date05/16/2011
Withdrawal Date 03/18/2013
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR CHANGES TO THE QUALITY SYSTEM DRAWINGS OF TEN RECEIVER AND TRANSMITTER COMPONENTS, USED FOR FIRST ARTICLE INSPECTION ACTIVITIES PRIOR TO RELEASE FOR MANUFACTURING.
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