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Trade Name | (MRU) Percept and Activa Dystonia Therapy Systems |
Classification Name | implanted subcortical electrical stimulator (motor disorders) |
Generic Name | implanted subcortical electrical stimulator (motor disorders) |
Applicant |
MEDTRONIC NEUROMODULATION |
7000 central avenue ne |
rcw 225 |
minneapolis, MN 55432 |
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HDE Number | H020007 |
Supplement Number | S257 |
Date Received | 10/18/2019 |
Decision Date | 06/24/2020 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Which requested approval for the following:• model b35200 percept pc implantable neurostimulator (ins);• model b31060 connector plug;• updates to the model a610 clinician programmer application (ppa) software to version 2. 0;• updates to the model a620 patient programmer application (cpa) to version 2. 0;• updates to the model 8880t2 communicator (clinician telemetry device) firmware; • new model th91 handset and communicator kit; and• labeling changes in physician and patient labeling for existing products, to be consistent with the proposed labeling for the new percept pc system. |