St. Jude Medical Resolves FDA Warning Letter for Sylmar Facility
ST. PAUL, Minn. -- July 2, 2014
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced
that it has been notified by the U.S. Food and Drug Administration (FDA) that
issues cited in the Sylmar, Calif., facility’s warning letter have been
“We take our responsibility as a medical device manufacturer very seriously.
We are encouraged by the resolution of the FDA’s warning letter and will
continue to work to ensure the highest standards are met across our
manufacturing facilities,” said Dan Starks, Chairman, President and Chief
Executive Officer at St. Jude Medical. “St. Jude Medical is committed to
providing our patients, customers and regulators with products and services
that meet or exceed their expectations of safety, high-quality performance,
reliability and service.”
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.
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 March 29, 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.
St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Micki Sievwright, 651-756-4615
Press spacebar to pause and continue. Press esc to stop.