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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameFREESTYLE NAVIGATOR
Classification Namesensor, glucose, invasive
Generic Namecontinuous glucose monitor
ApplicantABBOTT LABORATORIES
PMA NumberP050020
Supplement NumberS003
Date Received04/21/2008
Decision Date05/21/2008
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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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