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In Brief: Kensey Nash Angio-Seal

This article was originally published in The Gray Sheet

Executive Summary

Kensey Nash Angio-Seal: U.S. approval of the 8 French arterial puncture sealing device "should be forthcoming," the company says July 23 in announcing that FDA's Seattle District has stated that it is "prepared to endorse to FDA headquarters" a pending premarket approval application for the device. The district office's recommendation follows an inspection of the American Home Products facility in Bothell, Washington where the device will be manufactured. Formal approval of the device should follow "pending approval of final labeling," Kensey Nash says. The firm received an approvable letter from FDA in July 1995 for Angio-Seal, which will be marketed domestically by AHP's Sherwood-Davis & Geck subsidiary...

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