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Trade Name | Activa® Dystonia Therapy System, SenSight™ Directional Lead Kit |
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 | S300 |
Date Received | 08/11/2021 |
Decision Date | 09/09/2021 |
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 add a duplicate inspection to the sensight lead stringing work instructions for sensight lead coil subassemblies used in models b33005 and b33015. The updated manufacturing process impacts subcomponents for the sensight directional lead occurring at the medtronic danvers facility located in danvers, ma. |