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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
Generic NameSensor, glucose, invasive
ApplicantAbbott Laboratories
1360 South Loop Road
Alameda, CA 94502
PMA NumberP050020
Supplement NumberS003
Date Received04/21/2008
Decision Date05/21/2008
Withdrawal Date 03/18/2013
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR TWO LABELING MODIFICATIONS: 1) TO MODIFY A WARNING REGARDING USE OF THE SYSTEM IN AN ENVIRONMENT WHERE ANESTHETIC GAS IS USED TO INSTEAD WARN AGAINST USE IN ENVIRONMENTS THAT CONTAIN ANY COMBUSTIBLE GAS; AND 2) TO ADD LANGUAGE TO THE INSTRUCTIONS FOR MUTING ALARMS TO CLARIFY WHEN IT IS NOT RECOMMENDED TO DO SO AND ALSO TO CLARIFY WHEN THE SYSTEM WILL GO INTO ABANDON ALARM MODE WHEN THE ALARMS ARE MUTED.
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