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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 NameADVISA DR MRI A2DR01
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator
Applicant MEDTRONIC INC.
PMA NumberP980035
Supplement NumberS334
Date Received06/11/2013
Decision Date12/06/2013
Product Code
NVZ[ Registered Establishments with NVZ ]
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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