Women's Health Weekly
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Breast Implants
U.S. FDA seeks more information on cohesive gel breast implant PMA application
May 5th, 2005
Inamed Corporation, a global healthcare company, announced that it has received a letter from the U.S. Food and Drug Administration (FDA) with respect to its Style 410 cohesive gel-filled breast implants premarket approval (PMA) application. The letter outlines the additional information that Inamed must provide before the FDA can complete its review of Inamed's Style 410 PMA. According to the letter, submission of this requested information is necessary in order for the FDA to determine whether there is reasonable assurance that the Style 410 breast implants are safe and effective for their intended use. "We acknowledge and appreciate the review to...
Source: Women's Health Weekly (2005-05-05)
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