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In Brief: Endosonics

This article was originally published in The Gray Sheet

Executive Summary

Endosonics: Receives go-ahead from FDA to market its Oracle Micro Plus family of combination percutaneous transluminal coronary angioplasty/ultrasound imaging catheters via premarket approval application supplement. Introduction in the U.S. is slated for the third quarter of 1995 with worldwide launch programs "planned prior to the end of this year," the firm states. The devices can both perform PTCA and image the lumen and artery wall. The supplement, submitted in November 1994, builds on the Pleasanton, California-based firm's September 1994 PMA for the first Oracle Micro system...

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