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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 THERAPY FOR DEEP BRAIN STIMULATION
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Generic Nameimplantable electrical thalmic stimulation system - deep brain stimulation
ApplicantMEDTRONIC NEUROLOGICAL
PMA NumberP960009
Supplement NumberS042
Date Received09/17/2007
Decision Date10/17/2007
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for te addition of a precaution to patient manuals of the model 7436 and model 7438 therapy controllers.
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