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Drug & Device News

By ALM Staff | Law Journal Newsletters |
October 31, 2005

Another Step Taken Toward Approval of Silicone Breast Implant Sales

The FDA in September issued an approvable letter to Inamed Corp. for its premarket application (PMA) for silicone gel-filled breast implants. An approvable letter is one of several intermediate steps in the FDA review process of new products but it does not mean that Inamed's device is yet approved by the agency. Previously, at its April 2005 meeting, the 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 the 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 its Style 153 device, which had raised particular safety issues for the panel.

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