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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.
Device(MBX, MHY, NHL, PJS) -Master Percept and Activa Deep Brain Stimulation Therapy Systems
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMEDTRONIC Inc.
MINNEAPOLIS, MN 55432-3576
PMA NumberP960009
Supplement NumberS361
Date Received10/18/2019
Decision Date06/24/2020
Product Code MHY 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the following:1) Model B35200 Percept PC Implantable Neurostimulator (INS);2) Model B31060 Connector Plug;3) Updates to the Model A610 Clinician Programmer Application (PPA) Software to version 2.0;4) Updates to the Model A620 Patient Programmer Application (CPA) to version 2.0;5) Updates to the Model 8880T2 Communicator (clinician telemetry device) firmware; 6) New Model TH91 Handset and Communicator kit; and7) Labeling changes in physician and patient labeling for existing products, to be consistent with the proposed labeling for the new Percept PC System.