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. |
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Device | (MBX, MHY, NHL, PJS) -Master Percept and Activa Deep Brain Stimulation Therapy Systems |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S361 |
Date Received | 10/18/2019 |
Decision Date | 06/24/2020 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |
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