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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 NameMEDTRONIC MINIMED PARADIGM REAL-TIME REVEL PUMP, PARADIGM REAL-TIME PUMP, AND GUARDIAN REAL-TIME MONITOR
Classification Namesensor, glucose, invasive
Applicant MEDTRONIC INC.
PMA NumberP980022
Supplement NumberS104
Date Received11/21/2011
Decision Date03/28/2012
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to 1) add the bayer contour link wireless meter to the list of meters, in the labeling, that can communicate with the paradigm real-time revel system (mmt-523, mmt-723, mmt-523k, mmt-723k); 2) add the bayer contour next link wireless meter to the list of meters , in the labeling, that can communicate with the paradigm real-time revel system (mmt-523, mmt-723, mmt-523k, mmt-723k), paradigm real-time system (mmt-522, mmt-722, mmt-522k, mmt-722k), and the guardian real-time continuous monitoring system (css7100, css7100k); and 3) enable the bayer contour next link wireless meter to facilitate transfer of data from the paradigm real-time revel system (mmt-523, mmt-723, mmt-523k, mmt-723k), paradigm real-time system (mmt-522, mmt -722, mmt -522k, mmt -722k}, and the guardian real-time continuous monitoring system (css7100, css7100k) to the carelink therapy management software (mmt-7333, mmt-7335) via the meter usb port.
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