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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 NameMYSENTRY SYSTEM
Classification Namesensor, glucose, invasive
Applicant MEDTRONIC INC.
PMA NumberP980022
Supplement NumberS075
Date Received05/25/2010
Decision Date12/20/2011
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the mysentry system, which includes a monitor/ (mmt-9101) and a remote outpost (mmt-9102), for use with the paradigm real-time system. The new manufacturing facility for the mysentry system is flextronics industrial (shenzhen) co. , ltd, located in shenzhen, china.
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