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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameREVO DR MRI RVDR01
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Applicant MEDTRONIC INC.
PMA NumberP090013
Supplement NumberS105
Date Received06/11/2013
Decision Date12/06/2013
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product 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.
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