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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 NumberS007
Date Received08/04/2008
Decision Date08/25/2008
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to combine three separate manual processes into a semi-automated process and a vendor change from asahi polyslider to oberg industries.
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