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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 FAMILY/SOLETRA/KINETRA/LEADS/EXTENSIONS/ADAPTORS INS
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Applicant MEDTRONIC INC.
PMA NumberP960009
Supplement NumberS125
Date Received07/29/2011
Decision Date08/26/2011
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to the manual for the model 8840 nvision clinician programmer. These changes include the addition of precautions related to modification of the device, the effect of electromagnetic interference (emi) on telemetry communication, and the effects of battery corrosion. The changes also include updates to existing precautionary language to maintain consistency with other medtronic labeling for external programming devices.
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