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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 NameCGMS IPRO CONTINUOUS GLOCOSE MONITORING SYSTEM
Classification Namesensor, glucose, invasive
ApplicantMEDTRONIC MINIMED, INC.
PMA NumberP980022
Supplement NumberS047
Date Received02/09/2009
Decision Date04/06/2009
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 a modification to the solutions software for the cgms ipro continuous glucose recorder (mmt-7319) to add an auto detect feature to allow the software to automatically recognize the computer¿s active ports and to correct previously identified anomalies.
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