Cyberonics responds to warning letter:
This article was originally published in Clinica
Executive Summary
Cyberonics says it has responded to the FDA's warning letter, issued on December 22 2004. The agency had said the company's three written responses to a number of Form-483 inspectional observations had failed to address satisfactorily the relevant issues. CEO Robert Cummins said the response was lengthy and outlined measures taken and to be taken by the firm to improve its quality systems. The company is still hoping to receive PMA approval for its vagus nerve stimulation device for use in depression by the end of January, although a decision could be delayed until late March; the original PMA was rejected last August.