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Trade Name | Medtronic Dystonia Therapy System |
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 | S290 |
Date Received | 02/23/2021 |
Decision Date | 05/07/2021 |
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 Approval for software changes to the medtronic model a620 patient programmer application (ppa) which consist of 1) fixing a defect that prevents the software from communicating with certain model b35200 inss that have tel-m ids containing particular values, 2) updating the impedance test that is used to support the mri eligibility feature of the a620 ppa, and 3) other minor changes and bug fixes. |