Home » INAMED FILES AMENDMENT WITH FDA FOR BIODIMENSIONAL STYLE 410 MATRIX COHESIVE GEL IMPLANT PMA
INAMED FILES AMENDMENT WITH FDA FOR BIODIMENSIONAL STYLE 410 MATRIX COHESIVE GEL IMPLANT PMA
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.
BusinessWire
KEYWORDS FDAnews Device Daily Bulletin
Upcoming Events
-
25Apr
-
07May
-
14May
-
30May