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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.
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
PMA NumberP960009
Supplement NumberS179
Date Received09/09/2013
Decision Date10/03/2013
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 
Updates to the current final pack label printing equipment controller, which is used during the sterile final package operation at medtronic puerto rico operations company (mproc) in villalba, puerto rico.