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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 ACTIVA DEEP BRAIN STIMULATION (DBS) SYSTEM
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Generic Namestimulator, electrical, implanted, for parkinsonian tremor
ApplicantMEDTRONIC Inc.
PMA NumberP960009
Supplement NumberS037
Date Received02/06/2006
Decision Date03/01/2006
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor modifications to the labeling with respect to the mri (magnetic resonance imaging) instructions; and for removing the ?mri and activa therapy? appendix from the labeling and replacing it with a stand-alone mri guidelines document.
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