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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 CONTINUOUS GLUCOSE MONITORING SYSTEM
Classification Namesensor, glucose, invasive
Generic Namecontinuous glucose monitor
ApplicantABBOTT LABORATORIES
PMA NumberP050020
Supplement NumberS010
Date Received02/02/2009
Decision Date09/25/2009
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval new packaging and desiccant for the inserter subcomponent of the sensor delivery unit (sdu), which is a component of the freestyle navigator continuous glucose monitoring system. This modification to the original approved device results in a new sterilization configuration, a new package and new sterilization method (eo) for the sensor support mount subcomponent of the sdu, user assembly of the inserter with the sensor support mount section, new secondary containers for the subcomponents of the sdu section, and changes to sdu labeling corresponding to the packaging changes.
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