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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 NEUROSTIMULATOR, ACTIVA SC NEUROSTIMULATOR, ACTIVA RC NEUROSTIMULATOR AND EXTERNAL NEUROSTIMULATOR
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Applicant MEDTRONIC INC.
PMA NumberP960009
Supplement NumberS165
Date Received02/07/2013
Decision Date06/19/2013
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for firmware changes intended to correct device behaviors that result in temporary loss of stimulation (exception bit) and can affect programmed stimulation parameters (over-discharge).
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