|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||ADVISA, ENRHYTHM MRI|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Generic Name||implantable pulse generator, pacemaker (non-crt)|
|Supplement Type||real-time process|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a firmware update to version cm2490c_10v5 for the model 2490c carelink remote home monitor and for a firmware update to version cm2490g_14v2 for the 2490g medtronic carelink remote home monitor, model 2020a cardiosight reader, and 2020b carelink express monitor for the devices.