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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, electrical, implanted, for parkinsonian tremor
PMA NumberP960009
Supplement NumberS052
Date Received06/06/2008
Decision Date04/07/2009
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for new activa pc implantable neurostimulation system (ins), intended for deep brain stimulation (dbs). The device, as modified, will be marketed under the trade name activa pc and is indicated for the following: parkinson's control therapy bilateral stimulation of the internal globus pallidus (gpi) or the subthalamic nucleus (stn) using medtronic activa parkinson's control therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodoparesponsive parkinson's disease that are not adequately controlled with medication. Tremor control therapy unilateral thalamic stimulation by the medtronic activa tremor control system is indicated for the suppression of tremor in the upper extremity. The system is intended for use in patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability.