Women's Health Weekly
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Breast Implants
Approvable letter issued for silicone breast implants
October 27th, 2005
The U.S. Food & Drug Administration (FDA) has issued an approvable letter to Inamed Corp. 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 5-4 not to approve Inamed's PMA. Since then, Inamed has provided FDA with additional information to address the primary safety concerns discussed by the...
Source: Women's Health Weekly (2005-10-27)
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