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MENTOR SALINE BREAST IMPLANT PMA WILL BE READY IN AUGUST 1995

This article was originally published in The Gray Sheet

Executive Summary

MENTOR SALINE BREAST IMPLANT PMA WILL BE READY IN AUGUST 1995 for use of the device in breast augmentation, the company said June 2 at an FDA public hearing. Mentor is envisioning submission of a premarket approval application that includes one-year follow- up data in augmentation patients with collection of two- and three-year follow-up data after the implant is approved. FDA called the hearing to gain input on the timing of a call for PMAs on saline breast implants, which could affect the continued availability of the devices ("The Gray Sheet" May 9, p. 17). The agency issued a proposed call in January 1993 for the preamendment Class III products. After the agency finalizes the call, manufacturers will have 90 days in which to submit PMAs. The companies can continue marketing their products while their PMAs are under review.
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