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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
Applicant MEDTRONIC INC.
PMA NumberP960009
Supplement NumberS049
Date Received04/14/2008
Decision Date04/16/2010
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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