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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceACTIVA PARKINSONS CONTROL THERAPY
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP960009
Supplement NumberS039
Date Received05/15/2006
Decision Date07/27/2006
Product Code MHY 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE PLATFORM SOFTWARE ON THE MODEL 8840 N'VISION PROGRAMMING SYSTEM.
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