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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 NameMINILINK REAL-TIME SYSTEM
Classification Namesensor, glucose, invasive
Applicant MEDTRONIC INC.
PMA NumberP980022
Supplement NumberS119
Date Received07/12/2012
Decision Date12/26/2013
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 a new watertight tester accessory device as well as labeling changes related to new cleaning and disinfection protocols for the minilink transmitter and new watertight tester. The minilink transmitter (model mmt-7703) and the watertight tester (model mmt-7726) are components of the paradigm real-time revel system, guardian realtime system, and mini link real-time system.
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