|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||PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP,|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to the stack assemblies and battery tube assembly to comply with rohs (restriction of hazardous substances) requirements. These changes include changes to five components on the stack assembly, a change in material for the bare printed circuit boards (pcbs) of the stack assembly and battery tube assembly, and a change to the solder material (from tin/lead to tin/silver/copper) used on the pcbs.