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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 NameACTIVA FAMILY/SOLETRA/KINETRA IMPLANTABLE NEUROSTIMULATORS/LEADS/STEREOTACTIC FRAME LEAD KIT/EXTENSIONS/ADAPTORS/MAGNET
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Applicant MEDTRONIC INC.
PMA NumberP960009
Supplement NumberS104
Date Received12/07/2010
Decision Date01/05/2011
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Upgrade of software used for statistical process control and analysis of inspection data.
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