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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 NameKINETRA & SOLETRA FAMILY OF NEUROSTIMULATOR
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Generic Nameimplantable electrical thalmic stimulation system - deep brain stimulation
ApplicantMEDTRONIC NEUROLOGICAL
PMA NumberP960009
Supplement NumberS043
Date Received09/17/2007
Decision Date01/11/2008
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changing the surfactant used to help disperse polytetrafluoroethylene (ptfe) during the battery manufacturing process.
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