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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.
 
DevicePercept and Activa Deep Brain Stimulation Therapy Systems
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP960009
Supplement NumberS385
Date Received09/04/2020
Decision Date06/09/2021
Product Codes MBX MHY NHL PJS 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for 1) the Pain PC System for Spinal Cord Stimulation (SCS) which includes Implantable Neurostimulation Systems Vanta with AdaptiveStim and Sequentia LT; and 2) modified labeling for the Model B31060 Connector Plug to reflect its intended use with the Pain PC system.3) labeling updates for previously approved devices to be consistent with Pain PC system labeling.
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