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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 NEUROSTIMULATORS
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Generic Nameimplantable electrical thalmic stimulation system - deep brain stimulation
ApplicantMEDTRONIC NEUROLOGICAL
PMA NumberP960009
Supplement NumberS045
Date Received11/23/2007
Decision Date12/11/2007
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a paperless chart recorder to the sterilization operations at the juncos, puerto rico manufacturing facility.
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