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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
Generic Nameimplantable electrical thalmic stimulation system - deep brain stimulation
PMA NumberP960009
Supplement NumberS005
Date Received01/12/1999
Decision Date02/10/1999
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revisions to the existing model 7495 quadripolar extension kit used in conjunction with the medtronic activa tremor control system.