FDAnews Device Daily Bulletin

INAMED FILES AMENDMENT WITH FDA FOR BIODIMENSIONAL STYLE 410 MATRIX COHESIVE GEL IMPLANT PMA

Nov. 21, 2005
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INAMED, a global healthcare company, recently announced that it has submitted an amendment to its cohesive gel breast implant (BioDimensional 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.
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