Inamed McGhan
This article was originally published in The Gray Sheet
Executive Summary
Silicone gel-filled breast implant modular PMA filing is completed Dec. 31. The Santa Barbara firm's PMA is based on a 2,000-patient core study of the Style 410 silicone implant. Inamed also submitted data from adjunct clinical studies, which included over 23,000 patients. Competitor Mentor plans to file a silicone gel breast implant PMA in the first half of 2003 (1"The Gray Sheet" Nov. 11, 2002, p. 28)...