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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 TREMOR CONTROL SYSTEM
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Generic Nameimplantable electrical thalmic stimulation system - deep brain stimulation
ApplicantMEDTRONIC VASCULAR
PMA NumberP960009
Supplement NumberS009
Date Received01/18/2000
Decision Date03/21/2000
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for device and manufacturing process changes to the existing model 7424 itrel ii neurostimulator, and rebranding of this device under the new tradename, soletra model 7426 neurostimulator, for use in conjunction with the existing medtronic activa tremor control system.
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