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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 CONTINUOUS GLUCOSE MONITORING
Classification Namesensor, glucose, invasive
Applicant MEDTRONIC INC.
PMA NumberP980022
Supplement NumberS103
Date Received11/15/2011
Decision Date06/19/2012
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 a manufacturing process change to incorporate the addition of process water to a used batch of platinum plating solution for the sof sensor glucose sensors (models mmt-7002 and mmt-7003) that are components of the medtronic minimed continuous glucose monitoring system, the paradigm real-time system, the guardian real-time system, the cgms ipro system and the cgms ipro2 system.
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