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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.
 
DeviceSOLETRA, KINETRA, ACTIVA
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Generic Namestimulator, electrical, implanted, for parkinsonian tremor
Applicant
MEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP960009
Supplement NumberS155
Date Received08/20/2012
Decision Date09/13/2012
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of manufacturing equipment at yourmproc-juncos facility germane to itrel, synergy, restore, soletra, kinetra, interstim and enterra neurostimulator.
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