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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 NamePARADIGM REAL-TIME INSULIN PUMP
Classification Namesensor, glucose, invasive
Applicant MEDTRONIC INC.
PMA NumberP980022
Supplement NumberS108
Date Received01/24/2012
Decision Date03/30/2012
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternative super capacitor used on the interface board of the paradigm real-time insulin pump (models mmt-522, -522k, -722, -722k) and paradigm real-time revel insulin pump (models mmt-523, -523k, -723, -723k) which are components of the continuous subcutaneous glucose monitoring system.
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