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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 NumberS020
Date Received10/21/2009
Decision Date11/20/2009
Withdrawal Date03/18/2013
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
  We welcome your comments and feedback about Devices@FDA.
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