|Trade Name||REVO DR MRI RVDR01|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval of labeling changes to remove the restriction stating that the patient must be positioned within the bore such that the isocenter (center of the mri bore) is superior to the c1 vertebra or inferior to the t12 vertebra as well as to remove the requirement that mri scans not be performed on patients with other previously implanted medical devices.