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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 NumberS135
Date Received12/16/2011
Decision Date01/13/2012
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 
Addition of two new desktop welding stations with updated power supplies, and two process changes to include the consolidation of production laser weld program code and reducing frequency parameters for the welding process.