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. |
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Device | MYSENTRY SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S075 |
Date Received | 05/25/2010 |
Decision Date | 12/20/2011 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 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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