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Saline Breast Implant Makers Must Submit PMAs By Nov. 17, FDA Says

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers of saline breast implants have until Nov. 17 to file either a premarket approval application, product development protocol or an investigational device exemption for their products or remove them from commercial distribution, FDA says in an Aug. 19 final rule.

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FDA, Congress Examine Saline Implant Data; Silicone PMA Expected In 2002

Mentor and Inamed should reconvene focus groups to review patient labeling changes for saline-filled breast implants, FDA's General and Plastic Surgery Devices Panel recommended July 9 at its meeting in Gaithersburg, Maryland

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