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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMYSENTRY SYSTEM
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS075
Date Received05/25/2010
Decision Date12/20/2011
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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