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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Medtronic epilepsy device gets new panel date: FDA's neurological devices advisory panel will review a pre-market approval application for Medtronic's deep brain stimulation implant for epilepsy on March 12, after a November 2009 panel review of the device was postponed. The device is intended as an adjunct to drug therapy for reducing the frequency of seizures in patients with drug-refractory epilepsy with partial-onset seizures. Medtronic says it anticipates approval by this summer (1"The Gray Sheet" Nov. 30, 2009). The firm has marketed its Activa DBS therapy for Parkinson's and essential tremor for more than a decade, and is also pursuing a depression indication
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