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Trade Name | Activa® Dystonia Therapy System, Percept™ PC BrainSense™ |
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 | S340 |
Date Received | 03/08/2023 |
Decision Date | 03/10/2023 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement To update process monitoring controls (sample sizes and control limits) as part of the implementation of statistical process control (spc) program at medtronic vascular. |