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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 TRANSMITTER (MMT-7703)
Classification Namesensor, glucose, invasive
Applicant MEDTRONIC INC.
PMA NumberP980022
Supplement NumberS120
Date Received08/03/2012
Decision Date08/17/2012
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Transfer of the sub-assembly manufacturing processes of the minilink real-time transmitter (mmt-7703) from intricon corporation in arden hills, minnesota to an alternate manufacturing facility at intricon in admirax, singapore. The minilink real-time transmitter is a component of the devices.
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