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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 Nameimplantable electrical thalmic stimulation system - deep brain stimulation
ApplicantMEDTRONIC VASCULAR
PMA NumberP960009
Supplement NumberS037
Date Received02/06/2006
Decision Date03/01/2006
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Type Special Supplement
Supplement Reason labeling change - minor
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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