ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that it has been notified by the U.S. Food and Drug Administration (FDA) that issues cited in the Plano, Texas, facility’s warning letter have been addressed.
“We’re pleased to have resolved the concerns identified by the FDA at our Plano manufacturing facility," said Daniel J. Starks, chairman, president and chief executive officer at St. Jude Medical. “We take quality and compliance seriously and are committed to meeting and exceeding patient, physician and regulator expectations in these areas.”
About St. Jude Medical
St. Jude Medical is a global medical
device manufacturer dedicated to transforming the treatment of some of
the world’s most expensive epidemic diseases. The company does this by
developing cost-effective medical technologies that save and improve
lives of patients around the world. Headquartered in St. Paul, Minn.,
St. Jude Medical has four major clinical focus areas that include
cardiac rhythm management, atrial fibrillation, cardiovascular and
neuromodulation. For more information, please visit sjm.com
or follow us on Twitter @SJM_Media.
Forward-Looking Statements
This news release contains
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 that involve risks and uncertainties. Such
forward-looking statements include the expectations, plans and prospects
for the Company, including potential clinical successes, anticipated
regulatory approvals and future product launches, and projected
revenues, margins, earnings and market shares. The statements made by
the Company are based upon management’s current expectations and are
subject to certain risks and uncertainties that could cause actual
results to differ materially from those described in the forward-looking
statements. These risks and uncertainties include market conditions and
other factors beyond the Company’s control and the risk factors and
other cautionary statements described in the Company’s filings with the
SEC, including those described in the Risk Factors and Cautionary
Statements sections of the Company’s Annual Report on Form 10-K for the
fiscal year ended December 28, 2013 and Quarterly Report on Form 10-Q
for the fiscal quarter ended June 28, 2014. The Company does not intend
to update these statements and undertakes no duty to any person to
provide any such update under any circumstance.
