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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 (DBS) THERAPY
Classification Namestimulator, electrical, implanted, for parkinsonian tremor
Applicant MEDTRONIC INC.
PMA NumberP960009
Supplement NumberS106
Date Received12/21/2010
Decision Date01/20/2011
Product Code
MHY[ Registered Establishments with MHY ]
Advisory Committee Neurology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add new precautions required for compliance with applicable portions of the ¿iec 60601-1 standard for medical electrical equipment - part 1: general requirements for basic safety and essential performance. ¿.
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