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Boston Scientific Corporation met today with the U.S. Food and Drug Administration to discuss the company's plans for responding to the Corporate Warning Letter they received on January 26, 2006. The Company acknowledged the FDA's assessment of corporate-wide quality system and device reporting deficiencies and confirmed the firm's commitment to resolving all issues according to an aggressive timeline.
The FDA expressed its commitment to responding to any and all questions, plans and scheduling of verification inspections in an equally timely manner.
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