|Trade Name||REVO MRI IPG|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for software changes to the mycarelink patient monitor m2. 5 model 24950 with model 24955 rf head which supports the devices and medtronic¿s reveal insertable cardiac monitors models 9529, 9528 and lnq11. The mycarelink patient monitor is indicated for transmission of implantable device data to the carelink network for the clinic to review.