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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 NameSOLETRA AND ITREL II NEUROSTIMULATORS FOR DEEP BRAIN STIMULATION (DBS) SOFTWARE
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Generic Nameimplantable electrical thalmic stimulation system - deep brain stimulation
ApplicantMEDTRONIC VASCULAR
PMA NumberP960009
Supplement NumberS025
Date Received05/10/2002
Decision Date10/31/2002
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model 8870 n'vision application card. The model 8870 n'vision application card is an accessory to the soletra and itrel ii neurostimulators for dbs.
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