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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.
 
DeviceFREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
Applicant
Abbott Laboratories
1360 south loop road
alameda, CA 94502
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/material
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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