Inamed Receives FDA Letter Requesting Additional Information for Its Style 410 Cohesive Gel Breast Implant PMA Application

Business Wire, April 4, 2005

SANTA BARBARA, Calif. -- Inamed Corporation (NASDAQ:IMDC), 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 date of our Style 410 PMA by the Food and Drug Administration," said Nick Teti, Chairman, Chief Executive Officer and President of Inamed. "As has been our ongoing practice, we intend to work closely and cooperatively with the FDA in providing the additional information that will allow it to complete the review of our Style 410 PMA."

The Style 410 is Inamed's next generation cohesive gel-filled breast implant. It is designed for memory and shape retention, and is marketed internationally as the Bio-Dimensional(TM) Cohesive Gel(TM) Matrix (Style 410). The Style 410 breast implants are the preferred choice of breast implants by physicians and patients in countries where they are commercially available.

The Style 410 breast implants are not part of Inamed's PMA application to be considered at the FDA's Medical Devices Advisory Committee meeting on April 11-13, 2005, and the letter has no impact on the timing or substance of the matters to be considered at the April meeting.

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