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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 NameMEDTRONIC ACTIVA TREMOR CONTROL SYSTEM
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Generic Nameimplantable electrical thalmic stimulation system - deep brain stimulation
ApplicantMEDTRONIC VASCULAR
PMA NumberP960009
Supplement NumberS001
Date Received11/19/1997
Decision Date03/27/1998
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for three of the four conditions of approval, i. E. , studies to further characterize long term safety and effectiveness, obtain follow-up mortality and autopsy information, and evaluate patients following implantation of multiple leads and implantation of replacement leads.
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