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Fusion Medical Technologies

This article was originally published in The Gray Sheet

Executive Summary

Firm's FloSeal matrix hemostatic sealant receives "streamlined" premarket approval review status from FDA and will not require panel review, the firm reports April 27. With the streamlined review status, the Mountain View, California-based firm says it has requested a "100 day" meeting with the agency "to discuss any outstanding issues" concerning approval. Fusion estimates that the meeting will occur in June

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