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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 NameDBS IMPLANTABLE NEUROSTIMULATORS
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Applicant MEDTRONIC INC.
PMA NumberP960009
Supplement NumberS152
Date Received07/23/2012
Decision Date12/03/2012
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for addition of the in-process inspection for the cathod mix used in battery models.
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