INAMED Files Amendment with FDA for BioDimensional™ Style 410 Matrix Cohesive Gel Implant PMASANTA BARBARA, Calif. -- INAMED Corporation (NASDAQ:IMDC), a global healthcare company, today announced that it has submitted an amendment to its cohesive gel breast implant (BioDimensional(TM) Style 410 Matrix) premarket approval application (PMA) currently under review by the Food and Drug Administration (FDA). The Style 410 PMA was submitted to the FDA in December 2004. Among other information submitted to the FDA, the Company provided 3-year follow-up data from the Style 410 Core Study cohort and new 5-9-year rupture prevalence data from a European study. "We are pleased to have submitted this amendment to our Style 410 PMA," said Nick Teti, Chairman, President and Chief Executive Officer. "We look forward to continuing our discussions with the FDA regarding this important product." The innovative BioDimensional Style 410 is the next generation of cohesive gel implant in INAMED's pipeline undergoing U.S. clinical studies. The product is designed for memory and shape retention and has been available internationally for almost 10 years. |
Home About This Site Find an Expert Cohesive Breast Implant Surgeon Cohesive Breast Implant Trials in the USA About Cohesive Breast Implants Cohesive Breast Implant FAQ History of Cohesive Breast Implants Advantages / Disadvantages of Cohesive Breast Implants Cohesive Implants in the News Before and After Photos Publications, References, and Links Ask A Question Contact Us Site Map |