This
press release is posted as a service by Angioplasty.Org
FDA Statement Regarding
Boston Scientific Corporation
Boston Scientific Corporation met today with the U.S. Food & 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.
Source: U.S. Food and Drug Administration
