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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 NameDEEP BRAIN STIMULATION FAMILY OF NEUROSTIMULATION LEADS
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Generic Namestimulator, electrical, implanted, for parkinsonian tremor
ApplicantMEDTRONIC Inc.
PMA NumberP960009
Supplement NumberS070
Date Received08/24/2009
Decision Date10/15/2009
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate manufacturing site located at benchmark electronics, inc. , winona, minnesota for the manufacture of the medtronic model 3625 test stimulator.
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