Inamed augments PMA filing
This article was originally published in The Gray Sheet
Executive Summary
Supplemental data for firm's silicone gel-filled breast implants have been submitted to FDA, company announces Aug. 19. The addition responds to a January FDA non-approvable letter (1"The Gray Sheet" Jan. 12, 2004, p. 3). Inamed also has filed seven-year follow-up data on saline implants, required as a condition of May 2000 PMA approval, according to an Aug. 12 release (2"The Gray Sheet" May 15, 2000, p. 15). The data found a 9.8% deflation rate for the 876-patient augmentation cohort and 12.4% deflation for the 194-patient reconstruction cohort...
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