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In Brief: Possis Medical Perma-Seal

This article was originally published in The Gray Sheet

Executive Summary

Possis Medical Perma-Seal: Dialysis access graft revised 510(k) submission planned for the first calendar quarter of 1997, the firm states. Based on a recent "clarification" of FDA's "expectations" for an "on-going study...we now project it will likely be late calendar 1996 before we will have the FDA-required number of patients followed for 12 months," the firm says. Possis' original 510(k) was submitted in August 1994; the firm acknowledged additional information would be required in March 1995 ("The Gray Sheet" April 3, 1995, In Brief). The devices are expected to come to market outside the U.S. "in the fourth quarter of this year" under an agreement with C.R. Bard...



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