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Advanced Bionics
Advanced Bionics Reaches Resolution With FDA, Settles Financial Suit
August 8th, 2008
Advanced Bionics agreed to settle an administrative complaint arising from a disagreement with the U.S. Food and Drug Administration (FDA). The FDA asserted that Advanced Bionics should have made a formal submission five years ago before using a second vendor for a particular component in its cochlear implant system. The component, called a feedthru, contained a hidden weakness that allowed a very slow leak of water molecules into the implanted devices containing this vendor's feedthrus while blocking the passage of much smaller helium and nitrogen gases. Until this situation, such a condition was universally believed to be impossible. After an extended period of one year or more, the slow...
Source: Health Business Week (2008-08-08)
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