Guidant Announces Completion of FDA Inspection of St. Paul Facilities; Company Reports One Inspection Observation and Reiterates
February 23 2006 - 7:31AM
Business Wire
Guidant Corporation (NYSE:GDT) announced today that the U.S. Food
and Drug Administration (FDA) has completed an inspection of
Guidant's Cardiac Rhythm Management facilities in St. Paul,
Minnesota, and has provided Guidant a Form FDA-483, noting one
inspection observation. The inspection was initiated on December
15, 2005, and concluded on February 9, 2006, and was not an
assessment of the adequacy of Guidant's response to its Form
FDA-483 dated September 1, 2005, or Warning Letter dated December
22, 2005. Guidant will provide the FDA with a thorough written
response to the single observation in early March. From a Quality
System perspective, FDA's observation is similar to an observation
included in its previous Form FDA-483, though it references a
different event pattern recently identified by the company. The
company has already completed much of the work it believes is
required to address the observation on a system-wide basis. The
Company anticipates being ready for the follow-up inspection by mid
2006. While still undergoing analysis, the low frequency pattern
was classified by the company as a pattern in November 2005 and
will be referenced in the 1st Quarter 2006 edition of the Guidant
Cardiac Rhythm Management Product Performance Report, scheduled to
be available on the company's website tomorrow. In the 4th Quarter
2005 edition of the report, the events in the pattern appeared as
"non-patterned" events, since this report reflected data and
understanding current as of August 29, 2005. Additional details on
the pattern and a copy of the Form FDA-483 can be viewed at
http://www.guidant.com/physician/Form483/. 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. NOTE TO MEDIA: For more information about
Guidant, including products, services and patient profiles, please
visit the company's newsroom at www.guidant.com/newsroom. This
release includes forward-looking statements. The statements are
based on assumptions about many important factors, including the
adequacy of the work completed to date by the company in response
to the previous Form FDA-483 and the relevance of that work to the
FDA's additional observation, and other factors identified in Item
1A of the company's most recent filing on Form 10-K. Actual results
may differ materially. The company does not undertake to update its
forward-looking statements.
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