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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.
 
DeviceACTIVA TREMOR CONTROL THERAPY SYSTEM
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Generic Namestimulator, electrical, implanted, for parkinsonian tremor
Applicant
MEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP960009
Supplement NumberS020
Date Received07/10/2001
Decision Date08/10/2001
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Typespecial (immediate track)
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of an additional quality contorol process step to verify that neurostimulators are manufactured to their specification, e. G. , the neurostimulator has the specified insulation between the battery and the internal surface of the titanium case (shield).
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