4 avril, 2005 02:20
Inamed gets FDA request for information
APR. 4 1:30 P.M. ET Health-care company Inamed Corp. said Monday that the Food and Drug Administration requested further information regarding its premarket approval application for its Style 410 cohesive gel-filled breast implants.
The company, which specializes in implants, wrinkle-fighting products and obesity treatment devices, said the FDA requires the information to determine whether the implants are safe and effective. The implant is designed for memory and shape retention, and is marketed internationally as the Bio-Dimensional Cohesive Gel Matrix (Style 410).
Inamed but did not disclose specific details of the FDA's request in a press release, but said it plans to work closely with the FDA to provide the information.
The company said the regulator's request will have no impact on an application that will be considered by an FDA committee in mid-April.
The FDA rejected a bid by Inamed in January last year to bring back silicone implants, which have been banned for most patients since 1992.
Inamed shares fell $2.07, or 2.9 percent, to $68.49 in afternoon trading on the Nasdaq.
