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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 NumberS002
Date Received04/02/2008
Decision Date05/15/2008
Withdrawal Date03/18/2013
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
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR: 1) THE ADDITION OF A CARBON COATING TO THE BACK OF THE SENSOR TAIL TO IMPROVE ADHESION OF THE MEMBRANE IN ORDER TO ELIMINATE MICROSCOPIC MEMBRANE FRAGMENTATION; 2) A CHANGE IN THE ORIENTATION OF THE POSITION OF THE SENSOR DURING THE MANUFACTURING PROCESS TO FACILITATE INSPECTION; 3) A LABELING CHANGE, RESULTING FROM THE BACKSIDE CARBON COATING, TO ELIMINATE A CAUTION REGARDING MEMBRANE FRAGMENTS REMAINING IN THE SKIN; 4) AND A CHANGE IN A SUB-SUPPLIER MANUFACTURING SITE, DUPONT, HOPEWELL, VIRGINIA.
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