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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 NumberS021
Date Received09/19/2001
Decision Date10/19/2001
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Type Special Supplement
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the manufacturing process to add quality control process steps to verify that the deep brain stimulation leads, models 3387 and 3389, are manufactured to their specification.
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