Healthcare Industry News: Guidant
News Release - April 16, 2007
Boston Scientific Resolves CRM Warning Letter Deficiencies
NATICK, Mass., April 16 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today announced that the Company has resolved the deficiencies in the warning letter issued by the U.S. Food and Drug Administration (FDA) to the Guidant Corporation on December 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, Minnesota between November 9 and December 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."
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific.com.
This press release contains forward-looking statements. The Company wishes to caution the reader that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with the regulatory process, competitive product offerings, integration of acquired companies and other factors described in the Company's filings with the Securities and Exchange Commission.
Source: Boston Scientific
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