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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.
 
Trade NamePRARDIGM REAL-TIME INSULIN PUMPS AND GUARDIAN REAL-TIME MONITOR
Classification Namesensor, glucose, invasive
Applicant MEDTRONIC INC.
PMA NumberP980022
Supplement NumberS116
Date Received03/26/2012
Decision Date05/24/2012
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of a change of the field effect transistor (fet), a component of the paradigm real-time revel insulin pumps (models mmt-523, mmt-723, mmt-523k, mmt-723k), the paradigm real-time insulin pumps (models mmt-522, mmt-722, mmt-522k, mmt-722k), and the guardian real-time monitor (models css7100 and css7100k), which are components of the paradigm real-time and guardian real-time systems.
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