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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.
Classification Namesensor, glucose, invasive
PMA NumberP980022
Supplement NumberS156
Date Received04/29/2014
Decision Date10/02/2014
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to replace the current holder (blue test plug) used as a production aid during sub-assembly manufacturing of the minilink (mmt-7703) and ipro2 (mmt-7741) transmitters to two new holders. The minilink transmitter is a component of the paradigm real-time, paradigm real-time revel, guardian real-time, minilink real-time and minimed 530g systems. The ipro2 transmitter is a component of the ipro2 professional continuous glucose monitoring system.