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March 1, 2010

Guidant Charged with Criminal Violations

Guidant has been charged with criminal violation under the Federal Food, Drug and Cosmetic Act by the US Justice Department. The medical device manufacturer is believed to have concealed information from the US Food and Drug Administration on the failures of its implantable cardioverter

By cms admin

Guidant has been charged with criminal violation under the Federal Food, Drug and Cosmetic Act by the US Justice Department.

The medical device manufacturer is believed to have concealed information from the US Food and Drug Administration on the failures of its implantable cardioverter defibrillators (ICDs).

ICDs are used for the detection and treatment of abnormal heart rhythms that can result in sudden cardiac death and if the device fails to function properly, a person can die within minutes.

The corporation had in November 2009 agreed to pay $296m in connection with these charges.

Guidant is a wholly owned subsidiary of Boston Scientific.

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