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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 NameNEUROSTIMULATION SYSTEM FOR DEEP BRAIN STIMULATION (DBS)
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Applicant MEDTRONIC INC.
PMA NumberP960009
Supplement NumberS193
Date Received03/31/2014
Decision Date04/30/2014
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to provide corrections to the labeling related to the cycling feature (alternating between therapy off and on) in some neurostimulation devices used for spinal cord stimulation and deep brain stimulation.
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