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The U.S. Food and Drug Administration (FDA) today issued an approvable letter to Inamed Corporation for its premarket application (PMA) for silicone gel-filled breast implants. Federal law and regulations prohibit the government from discussing the specific contents of the letter. However, an approvable letter is one of several intermediate steps in the FDA review process of new products. Previously at its April 2005 meeting, FDA’s General and Plastic Surgery Devices Advisory Panel recommended by a vote of 5 to 4 not to approve Inamed’s PMA. Since then, Inamed has provided FDA with additional information to address the primary safety concerns discussed by the Panel. Inamed has also said that it will no longer make available Style 153, which raised particular safety issues for the Panel. The approvable letter does not mean that Inamed’s device is approved for marketing in the United States at this time.
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