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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 NameMEDTRONIC NEUROMODULATION DEEP BRAIN STIMULATION SYSTEMS
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Applicant MEDTRONIC INC.
PMA NumberP960009
Supplement NumberS073
Date Received12/03/2009
Decision Date06/01/2010
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revised labeling for the device. The changes consist of organization, editorial, and content revisions, which include the addition of new warnings and contraindications.
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