Advanced Bionics/FDA settlement
This article was originally published in The Gray Sheet
Executive Summary
Cochlear implant maker settles July 14 with FDA over allegations filed in late 2007 that the firm did not properly submit a PMA supplement when it added a vendor for a component of its HiRes90K device and violated quality system regulations (1"The Gray Sheet" April 21, 2008, p. 15). Advanced Bionics will pay FDA a civil money penalty of $1.1 million and CEO Jeff Greiner will pay $75,000 (down from $1.1 million previously sought). Neither the firm nor Greiner admits liability under the agreement
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