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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.
 
DeviceMEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
Applicant
MEDTRONIC MINIMED
18000 devonshire st
northridge, CA 91325
PMA NumberP980022
Supplement NumberS103
Date Received11/14/2011
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 - manufacturer/sterilizer/packager/supplier
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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