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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 PUMPS;PARADIGM REAL-TIME REVEL INSULIN PUMPS
Classification Namesensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
PMA NumberP980022
Supplement NumberS133
Date Received03/27/2013
Decision Date01/15/2014
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the reduction of keypad button (dome) sizes, new keypad overlay supplier (bergquist), and keypad/ overlay/ case assembly process for the paradigm real-time insulin pumps (models: mmt-522, mmt-522k, mmt-722, mmt-722k and paradigm real-time revel insulin pumps (models: mmt-523, mmt-523k, mmt-723, and mmt-723k) that are components of the paradigm real-time and paradigm real-time revel systems, respectively.
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