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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
PMA NumberP980022
Supplement NumberS106
Date Received12/14/2011
Decision Date12/28/2011
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in manufacturing location from thailand to moorpark, ca for cts electronics manufacturing solutions, inc. (cts), the supplier of the printed circuit board assemblies (pcba), for the paradigm real-time insulin pumps (models mmt-522, mmt-522k, mmt-722, mmt-722k, mmt-523, mmt-523k, mmt-723, mmt-723k), which are components of the device.