Women's Health Weekly
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Breast Implants
U.S. FDA schedules advisory hearing for silicone-gel-filled breast implant PMA
January 6th, 2005
Mentor Corp. (MNT) has been notified by the U.S. Food and Drug Administration (FDA) that the company's silicone-gel-filled breast implant premarket approval (PMA) application will be reviewed by an FDA scientific advisory panel, scheduled for the spring of 2005. "We believe that the data from our core clinical study, together with the supplemental data we have provided, support the safety and effectiveness of these products. Mentor has a long heritage of innovation in surgical devices and patient care, and has been able to meet the increasingly sophisticated needs of physicians and evolving needs of patients," commented Joshua H. Levine, president and chief executive...
Source: Women's Health Weekly (2005-01-06)
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