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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 NumberS002
Date Received04/02/2008
Decision Date05/15/2008
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 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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