|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||REVO MRI|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for firmware updates (version cm2490g_15v6) to the carelink monitor model 2490g carelink home monitors, model 2020a cardiosight reader, and model 2020b carelink express for a variety of implanted devices.