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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 NumberS010
Date Received02/02/2009
Decision Date09/25/2009
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
Approval Order Statement  
APPROVAL NEW PACKAGING AND DESICCANT FOR THE INSERTER SUBCOMPONENT OF THE SENSOR DELIVERY UNIT (SDU), WHICH IS A COMPONENT OF THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM. THIS MODIFICATION TO THE ORIGINAL APPROVED DEVICE RESULTS IN A NEWSTERILIZATION CONFIGURATION, A NEW PACKAGE AND NEW STERILIZATION METHOD (EO) FOR THE SENSORSUPPORT MOUNT SUBCOMPONENT OF THE SDU, USER ASSEMBLY OF THE INSERTER WITH THE SENSOR SUPPORTMOUNT SECTION, NEW SECONDARY CONTAINERS FOR THE SUBCOMPONENTS OF THE SDU SECTION, AND CHANGES TO SDU LABELING CORRESPONDING TO THE PACKAGING CHANGES.
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