Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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
Advertisement

Related Content

Advanced Bionics Requests Extra Time To Answer Amended FDA Complaint
Advanced Bionics Requests Extra Time To Answer Amended FDA Complaint
Advertisement
UsernamePublicRestriction

Register

MT026342

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel