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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 Deep Brain Stimulation Therapy System
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP960009
Supplement NumberS339
Date Received02/14/2019
Decision Date03/15/2019
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 to correct the value for the electrode surface area used in the charge density calculation from 0.12 cm2 to 0.06 cm2. The erroneous value of 0.12 cm2 is currently used in the calculation to display the charge density warning notification when the Activa CPA is used with an ENS and twist lock cable.
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