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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.
 
DeviceFREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantAbbott Laboratories
1360 South Loop Road
Alameda, CA 94502
PMA NumberP050020
Supplement NumberS012
Date Received03/13/2009
Decision Date05/08/2009
Withdrawal Date 03/18/2013
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE INSERTER COMPONENT HOUSING OF THE FREESTYLE CGMS, TO REDUCE THE OVERALL THICKNESS IN THE SHELVES OF THE HOUSING AND A CHANGE TO THE MANUFACTURING EQUIPMENT USED TO MOLD THE HOUSING COMPONENTS.
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