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Trade Name | Activa 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 | S186 |
Date Received | 05/03/2017 |
Decision Date | 05/25/2017 |
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 qualify an alternate balseal manufacturing site facility for the spring coil components (colorado springs) and to update the tooling used for the insertion testing of the contact assembly from a uni-directional test pin to a bi-directional test pin. |