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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 PC IMPLANTABLE NEUROSTIMULATOR, ACTIVA SC IMPLANTABLE NEUROSTIMULATOR, ACTIVA SC IMPLANTABLE NEUROSTIMULATOR,
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Applicant MEDTRONIC INC.
PMA NumberP960009
Supplement NumberS185
Date Received10/25/2013
Decision Date11/22/2013
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a new epoxy mixer component for the mta epoxy dispenser.
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