|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 Name||MINILINK REAL-TIME SYSTEM,IPRO RECORDER CGMS SYSTEM,IPRO2 RECORDER CGM SYSTEM|
|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 the supplier and material of the battery anode for the minilink real-time transmitter (model: mmt-7703), the ipro2 recorder (model: mmt-7741) and the minilink real-time transmitter (model: mmt-7703), which are components of the paradigm real-time, paradigm real-time revel, guardian real-time, minilink real-time, ipro2 professional cgm and minimed 530g systems.