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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 NumberS017
Date Received06/17/2009
Decision Date01/19/2010
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
Approval Order Statement  
APPROVAL FOR A PROCESS VALIDATION ON THE SHARP MANUFACTURED AT OBERG INDUSTRIES (IN FREEPORT, PENNSYLVANIA) AS WELL AS TO WIDEN DIMENSIONAL TOLERANCES ON THE SHARP IN BOTH LENGTH AND ANGLE BEND. CURRENTLY ALL SHARPS PRODUCED AT OBERG MUST UNDERGO 100% INSPECTION AT FACET (IN MARIETTA, GEORGA) PRIOR TO ITS ASSEMBLING INTO THE SENSOR INSERTER OF THE SENSOR DELIVERY UNIT (SDU) OF THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM. THE PROCESS VALIDATION PROVIDED IN THIS SUPPLEMENT WILL REPLACE THE 100% INSPECTION REQUIREMENT AT FACET.
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