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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 NameACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Applicant MEDTRONIC INC.
PMA NumberP960009
Supplement NumberS220
Date Received02/27/2015
Decision Date05/11/2015
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for material changes to two non-implantable screening cables (the alligator clip screening cable accessory kit and the twist lock screening cable accessory kit) to comply with the european union restriction of hazardous substances ii directive 2011/65/eu.
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