INAMED SEEKING PREMARKET APPROVAL FOR NEXT-GENERATION BREAST IMPLANTS

Inamed has filed a premarket approval (PMA) application with the FDA for Bio-Dimensional Cohesive Gel Matrix breast implants, designed for memory and shape retention.

The company added that it has been notified by the agency that its supplemental submission for its pending silicone-gel-filled breast implants PMA application is scheduled for review at a tentative General and Plastic Surgery Devices Advisory Panel Meeting in April.

According to the company, the Bio-Dimensional Cohesive Gel Matrix breast implants have been marketed outside of the U.S. since the mid-1990s and represent the fastest-growing breast implant product line in Inamed's global markets.