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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 NameACTIVA RC RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Applicant MEDTRONIC INC.
PMA NumberP960009
Supplement NumberS051
Date Received04/24/2008
Decision Date03/27/2009
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the following new components and accessories for the activa rc rechargeable implantable neurostimulation system: ¿ activa rc, model 37612 (neurostimulator) ¿ patient programmer, model 37642 ¿ model 8870 application card (activa rc) ¿ external neurostimulator, model 37022 ¿ 8-4 extension, model 37085 ¿ alligator clip screening cable. Model 3550-67 ¿ twist lock screening cable, model 3550-68 the activa rc rechargeable implantable neurostimulation system is indicated as follows: medtronic activa therapy includes activa parkinson's control therapy and activa tremor control therapy. 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, levodopa-responsive 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.
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