FDA meets with Guidant to discuss heart device defect

05/25/2005 | NYTimes.com

The Food and Drug Administration yesterday met with Guidant to discuss the company's disclosure this week that it failed to disclose a design flaw in an implantable defibrillator and did not reveal that the manufacturing process was changed in 2002 to fix it. Company officials said they followed FDA guidelines in reporting problems about the device to the agency.

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