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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.
Classification Namestimulator, autonomic nerve, implanted for epilepsy
PMA NumberP970003
Supplement NumberS166
Date Received11/13/2013
Decision Date05/09/2014
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling that describes the conditions under which magnetic resonance imaging (mri) can be used when residual vns leads or lead fragments (abandoned leads) remain in the body.