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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 PARKINSON'S CONTROL THERAPY
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Applicant MEDTRONIC INC.
PMA NumberP960009
Supplement NumberS060
Date Received12/19/2008
Decision Date11/25/2009
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Clinical Trials NCT00056563
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling update.
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