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Deaf Online _ Advanced Bionics _ FDA Seeks Civil Penalties from Calif. Device Maker

Posted by: Boult Mon Apr 7, 2008, 11:39 AM


http://bionicear.com/news_details.cfm?id=25&langid=1

Apr 7, 2008
Many of you have heard about the FDA's intent to fine Advanced Bionics. This announcement is about what happened five years ago in 2003. It's old news! We're trying to reach resolution with the FDA, but the process is complex and takes time. What you should take from these events is the following:


1. The fine is principally related to judgments the FDA is making about our quality system in 2003 --- five full years ago.


2. We are actively participating with the FDA to try and resolve these matters.


3. The process is complex and takes time.


4. The fine proposed by the FDA has no impact whatsoever on the ability of Advanced Bionics to operate its business.


5. The HiRes 90K is extremely reliable and, together with the Harmony, is the most durable implant system on the market.



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