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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 | S341 |
Date Received | 03/21/2023 |
Decision Date | 04/20/2023 |
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 implement new laser solder process parameters for the hybrid and battery connections of the percept pc (model b35200) and pain pc (model 977005 sequentia lt and model 977006 vanta with adaptivestim) neurostimulator devices. |