|Trade Name||MINILINK REAL-TIME TRANSMITTER, IPRO2 RECORDER|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| 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.