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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 INFUSINO PUMPS
Classification Namesensor, glucose, invasive
Generic Namecontinuous subcutaneous glucose monitoring system
Applicant MEDTRONIC INC.
PMA NumberP980022
Supplement NumberS031
Date Received08/06/2008
Decision Date03/10/2010
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the software modifications for model mmt-523, mmt-723, mmt-523k, and mmt-723k paradigm real-time insulin pumps as well as new versions of carelink pro and carelink personal accessory software that have been updated to support these insulin pump models.
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