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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.
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
Abbott Laboratories
1360 south loop road
alameda, CA 94502
PMA NumberP050020
Supplement NumberS031
Date Received10/25/2010
Decision Date11/23/2010
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 in the cleaning procedure of the reactors used to make the npbi mediator chemical used in the freestyle test strips and the time frame in which this cleaning process takes place.