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Mentor silicone submission

This article was originally published in The Gray Sheet

Executive Summary

Mentor has filed a PMA for its Contour Profile silicone gel breast implants, firm announces April 3. The Contour implants are filled with the same Memory Gel for which Mentor received an "approvable" letter for round implants from FDA last summer. Competitor Allergan/Inamed's silicone gel breast implants also sit on a September "approvable" letter. Though neither company will speculate, analysts project FDA approval of both firms' products as early as June 2006 (1"The Gray Sheet" April 3, 2006, p. 6). Furthering its shift to aesthetics, Mentor signed an agreement with Niadyne Inc. on March 20 to distribute Niadyne's NIA 24 skin therapy products...
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