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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.
 
DeviceMYSENTRY SYSTEM
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
Applicant
MEDTRONIC MINIMED
18000 devonshire st
northridge, CA 91325
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 change design/components/specifications/material
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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