19.01.2005 14:33:00
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Mentor Silicone Gel Breast Implant Product Approval Submissions to Be
Business Editors/Medical Editors
SANTA BARBARA, Calif.--(BUSINESS WIRE)--Jan. 19, 2005--
U.S. FDA General and Plastic Surgery Advisory Panel meeting scheduled for April 11-13, 2005; Health Canada Expert Advisory Panel
meeting scheduled for March 3-4, 2005
Mentor Corporation (NYSE:MNT), a leading supplier of medical products in the United States and internationally, today announced that it had been notified that the Company's silicone gel breast implant product approval submissions have been definitively scheduled for review by regulatory agencies in the United States and Canada.
The U.S. Food and Drug Administration (FDA) notified Mentor that the Company's pending pre-market approval application for its family of smooth and textured silicone gel-filled breast implants will be reviewed by the Agency's General and Plastic Surgery Advisory Panel at a meeting scheduled for April 11-13, 2005.
In addition, the Company announced that the Therapeutic Products Directorate of Health Canada will convene an Expert Advisory Panel meeting on March 3-4, 2005, to review Mentor's pending device license applications for its family of smooth and textured silicone gel-filled breast implant products and for its Contour Profile Gel breast implant products.
"We are pleased with the progress of the regulatory review processes in the U.S. and Canada," commented Joshua H. Levine, President and Chief Executive Officer of Mentor. "Our round and shaped breast implants command market-leading positions internationally and we hope in the future to be able to provide these important options to women in the U.S. and Canada."
Mentor's round and shaped silicone-gel filled breast implant products, filled with the Company's Memory Gel(TM), provide surgeons and patients with high quality options and are approved in more than fifty countries around the world.
About Memory Gel(TM)
Mentor's advanced Memory Gel is a proprietary silicone gel formulation used to fill all of Mentor's silicone gel-filled breast implants around the world. By varying the ratio of the components of the gel, Mentor is able to produce a wide selection of products that address the full range of customers' needs.
About Mentor Corporation
Founded in 1969, Mentor Corporation is a leading supplier of medical products for the global healthcare market. The Company develops, manufactures and markets innovative, science-based products for the aesthetics, urologic specialties and clinical and consumer healthcare markets around the world. The Company's website is www.mentorcorp.com.
Safe Harbor Statement
All statements included or incorporated by reference in this release, other than statements or characterizations of historical fact, are forward-looking statements. These forward-looking statements are based on our current expectations, estimates and projections about our industry, management's beliefs and certain assumptions made by us. Forward-looking statements can often be identified by words such as "anticipates," "scheduled," "expects," "intends," "plans," "predicts," "believes," "seeks," "estimates," "may," "will," "should," "would," "could," "potential," "continue," similar expressions, and variations or negatives of these words. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These forward-looking statements speak only as of the date hereof and are based upon the information available to us at this time. Such information is subject to change, and we will not necessarily inform you of such changes. These statements are not guarantees of future results and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statement as a result of various factors.
The Securities and Exchange Commission filings of Mentor, including, without limitation, its Annual Reports on Form 10-K, subsequent quarterly reports on Form 10-Q, and recent Current Reports on Form 8-K, discuss important risk factors that could contribute to such differences or otherwise affect its business, results of operations and financial condition. Mentor undertakes no obligation to revise or update publicly any forward-looking statement for any reason.
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CONTACT: Mentor Corporation Peter R. Nicholson, 805-879-6082
KEYWORD: CALIFORNIA INTERNATIONAL CANADA INDUSTRY KEYWORD: MEDICAL BANKING CONSUMER/HOUSEHOLD MEDICAL DEVICES PRODUCT SOURCE: Mentor Corporation
Copyright Business Wire 2005
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