Medical Devices

Implant maker comments on U.S. FDA panel's recommendations

Published in Medical Letter on the CDC and FDA, May 15th, 2005

Inamed Corporation (IMDC) commented on a decision by the General and Plastic Surgery Advisory Panel of the U.S. Food and Drug Administration (FDA) to recommend approval of Mentor Corporation's premarket approval (PMA) application to market the company's gel-filled breast implants in the United States.

Nicholas Teti, chairman, CEO and president of Inamed, released the following statement with respect to the FDA panel decision to approve Mentor's PMA: "Inamed views [this] panel decision as curious and inconsistent with the decision reached by the panel [previously] on Inamed's PMA - we look forward to working with Crawford and FDA staff on addressing these...

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Source: Medical Letter on the CDC and FDA (2005-05-15)

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