GDT Guidant Corp

Guidant Corporation (NYSE:GDT) announced today that the Company has published its responses to the Form 483 observations issued by the U.S. Food and Drug Administration (FDA). Guidant's responses address specific observations and detail broader steps that the Company intends to take to further enhance its Quality System. In these responses, certain limited information has been deleted (redacted) to the extent necessary to protect company competitive and proprietary information. The document can be reviewed at http://www.guidant.com/physician/Form483/. "Our decision to post our responses to the FDA 483 observations is a tangible demonstration of Guidant's intention to increase the flow of information with both physicians and patients," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "The Company is making substantial progress on the committed actions in our responses." On September 1, 2005, the FDA concluded an inspection of Guidant's Cardiac Rhythm Management facilities in St. Paul, Minnesota. The FDA provided Guidant Cardiac Rhythm Management with a Form 483, noting observations related to quality system requirements. FDA Form 483 is used to document observations made by FDA inspectors during the course of their inspection. Guidant provided the FDA with a thorough written response to each observation on September 15, 2005, describing the steps that Guidant had or would be taking to address the FDA's observations. The Company has submitted its first monthly update report to the FDA. Guidant Cardiac Rhythm Management conducted an extensive review of its Quality System in response to the FDA's observations. The Company fully recognizes the significance of the FDA's inspectional observations and the important opportunity they represent for continuous improvement. Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. The Company develops, manufactures and markets a broad array of products and services that enable less invasive care for some of life's most threatening medical conditions. For more information, visit www.guidant.com.