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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 NameCONTINUOUS GLOCOSE MONITORING SYSTEM
Classification Namesensor, glucose, invasive
Applicant MEDTRONIC INC.
PMA NumberP980022
Supplement NumberS071
Date Received04/22/2010
Decision Date10/20/2011
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Clinical Trials NCT00211510
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for incorporating a usb connection for data upload, changing the operating time before recharging, changing to a web-based software system, and incorporating a docking station and cleaning plug. The device, as modified, will be marketed under the trade name ipro2 professional continuous glucose monitoring (cgm) system (mmt-7745).
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