Teleflex Announces Receipt of Additional Approvals of Certificates to Foreign Governments from FDA
LIMERICK, Pa.--([ BUSINESS WIRE ])--Teleflex Incorporated (NYSE: TFX) today announced that it has received approval of a significant number of additional certificates to foreign governments (aCFGa) from the FDA, totaling forty-one approvals out of eighty-five submitted requests.
"I am very pleased by todaya™s announcement"
Beginning in the third quarter of 2010, the Company began submitting requests for CFGs to the FDA for review. The Company believes that the FDAa™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 FDAa™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.
aI am very pleased by todaya™s announcement,a stated Jeffrey P. Black, Chairman and Chief Executive Officer. aThe receipt of additional CFG approvals from the FDA will allow us to continue to provide critical medical devices that will enhance patient care in emerging markets and further our efforts to drive sustainable and profitable growth.a
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 managementa™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.