News | April 15, 2007

Boston Scientific Resolves FDA’s ’05 Guidant Deficiencies

April 16, 2007 — Boston Scientific Corp. has announced it has resolved the deficiencies in the warning letter issued by the U.S. Food and Drug Administration (FDA) to the Guidant Corp. on Dec. 22, 2005, and that all associated restrictions have been removed. Boston Scientific acquired Guidant last year.

The FDA re-inspected Guidant's cardiac rhythm management (CRM) facility in St. Paul, MN, between Nov. 9 and Dec. 7, 2006. The re-inspection included an assessment of Boston Scientific's implementation of quality system improvements in response to the warning letter. FDA inspectors noted no observations during the re-inspection.

"We are very pleased with the FDA's conclusion," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "This achievement is the result of a lot of hard work by employees across our CRM organization. The improvements made to our CRM quality system demonstrate our ongoing commitment to deliver the highest quality products to physicians and the patients they serve."

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