LIMERICK, Pa., Aug 04, 2010 (BUSINESS WIRE) --
Teleflex Incorporated (NYSE:TFX) today announced that it has received
approval of substantially all requests of certificates to foreign
governments ("CFG") from the FDA, totaling seventy-seven approvals out
of eighty-five submitted requests.
Beginning in the third quarter of 2010, the Company began submitting
requests for CFGs to the FDA for review. The Company believes that the
FDA's approval of these CFGs is a clear indication that it has
substantially corrected the quality system issues identified in the
corporate warning letter and continues to anticipate receiving the FDA's
approval with respect to most of these requests in the third quarter of
2010.
While the Company continues to believe it has substantially remediated
the issues raised in the corporate warning letter through the corrective
actions taken to date, the corporate warning letter remains in place
pending final resolution of all outstanding issues, which the Company is
actively working with the FDA to resolve.
"With the receipt of these additional CFG approvals, we look forward to
expanding the range of critical care products that we will be able to
provide to customers in Latin America, Southern and Eastern Europe and
the Middle East," stated Jeffrey P. Black, Chairman and Chief Executive
Officer. "Teleflex serves hospital customers in more than 140 countries
with critical medical devices and our international customers and
distribution channels will play an important role as we position the
company for future growth."
About Teleflex Incorporated
Teleflex is a global provider of medical technology products that enable
healthcare providers to improve patient outcomes, reduce infections and
support patient and provider safety. Teleflex, which employs
approximately 12,600 people worldwide, also has niche businesses that
serve segments of the aerospace and commercial markets with specialty
engineered products. Additional information about Teleflex can be
obtained from the Company's website at www.teleflex.com.
Forward-Looking Statements
Any statements contained in this press release that do not describe
historical facts may constitute forward-looking statements. Any
forward-looking statements contained herein are based on our
management's current beliefs and expectations, but are subject to a
number of risks, uncertainties and changes in circumstances, which may
cause actual results or company actions to differ materially from what
is expressed or implied by these statements. These risks and
uncertainties are identified and described in more detail in our filings
with the Securities and Exchange Commission, including our Annual Report
on Form 10-K.
SOURCE: Teleflex Incorporated
Teleflex Incorporated
Jake Elguicze
Vice President Investor Relations
610-948-2836