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Home » CYBERONICS 'OUTRAGED' BY FDA NOT-APPROVABLE DECISION
CYBERONICS 'OUTRAGED' BY FDA NOT-APPROVABLE DECISION
August 13, 2004
Cyberonics officials lashed out at the FDA last week after the agency issued a not-approvable ruling for the company’s implantable vagus nerve stimulation (VNS) therapy for patients with treatment-resistant depression. The ruling came roughly two months after an FDA advisory committee recommended approval of the device to treat depression.