Dec 27, 2005
Guidant Announces FDA Warning Letter Related to Prior FDA Inspection of St. Paul Facility

Company Will Promptly and Fully Respond to FDA

Indianapolis, Ind. - Guidant Corporation (NYSE: GDT) announced today that it has received a warning letter from the U.S. Food and Drug Administration (FDA) related to the FDA''s inspection of Guidant's Cardiac Rhythm Management facility in St. Paul, Minn. The FDA inspection was completed on September 1, 2005, and resulted in Form 483 observations as previously reported.

Guidant has taken a broad, thorough and systemic review of its quality system and has made substantial steps toward addressing all of the 483 observations. Guidant has provided the FDA with monthly updates on its progress and has thus far completed 90 percent of the commitments that it made in its initial response. The company is also tracking to an on-time completion of the remaining commitments. The 483 observations and Guidant''s initial response can be found at www.guidant.com/physician/Form483/.

The FDA letter, received December 23, 2005, references many of the 483 observations, noting actions taken by Guidant to address the observations and noting that Guidant will receive future communication regarding observations requiring additional action. The FDA letter also indicates that the FDA will not grant requests for exportation certificates to foreign governments or approve pre-market approval applications for class III devices that relate to observations requiring additional action, until such action has been completed. The company will promptly respond to the warning letter and believes that it can fully address the concerns of the FDA without a material impact to its business.

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.