Women's Health Weekly
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Breast Implants
Plans announced to file investigational device exemption with U.S. FDA for breast implants
October 27th, 2005
MediCor Ltd. (MDCR) announced that it plans to file for an investigational device exemption (IDE) with the U.S. Food and Drug Administration (FDA) in the first quarter of 2006 for high-consistency silicone-filled breast implants. IDE approval is the precursor to the company beginning clinical trials and filing for Premarket Approval (PMA) to market silicone-filled implants in the U.S. MediCor is a manufacturer and distributor of breast implants. The company markets silicone and saline-filled breast implants in more than 70 countries and has an approximate 30% non-U.S. global market share. The company is currently conducting U.S. Clinical trials for...
Source: Women's Health Weekly (2005-10-27)
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