FDA Releases Information from Mentor's Silicone Gel Breast Implant Approval Application.SANTA BARBARA, Calif. -- Mentor Corporation (NYSE NYSE See: New York Stock Exchange :MNT See molecular nanotechnology. ): --General And Plastic Surgery Devices Advisory Panel Meeting Scheduled for April 11-13, 2005 at the Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy, Gaithersburg, MD --Mentor To Present Data From Pivotal Core Gel Study On Wednesday, April 13, 2005 Mentor Corporation (NYSE:MNT), a leading supplier of medical products in the United States and internationally, today announced that the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has posted information related to Mentor's silicone gel breast implant breast implant, saline- or silicone-filled prosthesis used after mastectomy as a part of the breast reconstruction process or used cosmetically to augment small breasts. pre-market approval (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) application, scheduled to be reviewed at a General and Plastics Surgery Devices Advisory Panel meeting April 11-13, 2005, on its web site. The information can be viewed by accessing a link on Mentor's web site, www.mentorcorp.com, or by accessing the FDA web site directly, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfAdvisory/details.cfm?mtg=593. (Due to its length, this URL URL in full Uniform Resource Locator Address of a resource on the Internet. The resource can be any type of file stored on a server, such as a Web page, a text file, a graphics file, or an application program. may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.) Mentor's pivotal Core Gel Study followed 1,007 women who were implanted with silicone gel-filled breast implants Breast Implants Definition Breast implantation is a surgical procedure for enlarging the breast. Breast-shaped sacks made of a silicone outer shell and filled with silicone gel or saline (salt water), called implants, are used. for either augmentation, reconstruction or revision surgery. The data submitted to the FDA includes information from the 3-year follow-up period as well as longer-term clinical data specific to the integrity of Mentor's silicone gel-filled breast implants. The FDA General and Plastic Surgery Devices Advisory Panel meeting is scheduled for April 11-13, 2005. Mentor is scheduled to present its data on Wednesday, April 13th. About Mentor Corporation Founded in 1969, Mentor Corporation is a leading supplier of medical products for the global healthcare market. The Company develops, manufactures and markets innovative, science-based products for the aesthetics, urologic specialties and clinical and consumer healthcare markets around the world. The Company's website is www.mentorcorp.com. |
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