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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.
Classification Namesensor, glucose, invasive
Generic Namecontinuous subcutaneous glucose monitoring system
PMA NumberP980022
Supplement NumberS013
Date Received10/04/2005
Decision Date04/07/2006
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the mmt 515/715 external insulin pump and to the guardian rt sensor to enable the pump to accept data from the sensor, and to enable the sensor to communicate directly to the pump. The device will be manufactured at medtronic minimed, northridge, california.