Guidant (NYSE:GDT)
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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.