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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 | S200 |
Date Received | 09/20/2017 |
Decision Date | 10/20/2017 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | special (immediate track) |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of new safety information (tunneling procedure unintended nerve tissue injury warning and adverse event, loss of coordination precaution, weight gain/loss adverse event) and safety enhancement clarifications (update guidance on avoiding damage to the neurostimulator (physician labeling), clarify text that accompanies the figure for accurate right and left hemisphere lead-extension connection when placing dual lead systems (physician labeling), remove incorrect length of the dbs lead placed under the scalp (patient labeling)). |