|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 IPG|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the mycarelink patient monitor models 24950, 24951, reader model 24955, and accessories, which support the devices.