Mentor Submits Pre-Market Approval Application for Contour Profile Gel Breast Implant ProductsSANTA BARBARA, Calif. -- Mentor Corporation (NYSE:MNT), a leading supplier of medical products in the United States and internationally, today announced that it had filed its Pre-Market Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for the Company's Contour Profile(R) gel breast implant products (CPG(TM)). "Our CPG implants are market leading products in every country that they are available, and we are pleased to be in a position to seek approval for these products in the U.S. as well," commented Joshua H. Levine, President and Chief Executive Officer. "Their shape more closely imitates the natural breast, and would allow surgeons and their cosmetic and reconstructive patients to have more choices for breast surgery." Mentor's silicone gel-filled breast implants, including the CPG products, are filled with MemoryGel(TM). "All of Mentor's MemoryGel implants are filled with a proprietary silicone gel formulation that holds its shape but remains soft, resulting in a realistic feel and appearance," said Levine. "Because the personal needs of each patient vary, we are committed to offering experienced physicians more MemoryGel products that would enable them to achieve the most realistic breast contour." Mentor also remains in discussion with the FDA regarding the conditions for approval of the Company's MemoryGel round silicone gel breast implant PMA, including post-market patient monitoring. The Company submitted its PMA in December of 2003. In April 2005, Mentor received a recommendation for approval, with conditions, by an FDA Advisory Panel. In July 2005, the Company received an "approvable letter" from the FDA that stipulated a number of conditions which Mentor must satisfy in order to receive FDA approval to market and sell silicone gel-filled breast implants in the United States. There can be no assurances with respect to the timing and outcome of the FDA's decision regarding approval. |
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