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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 TRANSMITTER (MMT-7703) AND CGMS IPRO RECORDER (MMT-7709)
Classification Namesensor, glucose, invasive
Applicant MEDTRONIC INC.
PMA NumberP980022
Supplement NumberS115
Date Received03/08/2012
Decision Date04/26/2012
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change from a single cavity injection mold to a two cavity injection mold for the manufacture of the connector housing and contact components of the minilink transmitter (mmt-7703) and ipro digital recorder (mmt-7709). The minilink transmitter and ipro digital recorder are components of paradigm real-time, guardian real-time and ipro continuous glucose monitoring systems.
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