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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 NumberS020
Date Received10/21/2009
Decision Date11/20/2009
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
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