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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 NameGUARDIAN REAL-TIME MONITOR, MODEL CSS7100. CS7100K
Classification Namesensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
PMA NumberP980022
Supplement NumberS123
Date Received08/30/2012
Decision Date10/26/2012
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor software modifications in guardian® real-time system to optimize the shutdown procedure for the guardian monitor and to correct an anomaly that allowed access of out-of-bounds pointer errors.
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