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In Brief: PLC Systems

This article was originally published in The Gray Sheet

Executive Summary

PLC Systems: Firm's Heart Laser transmyocardial revascularization system likely will need to undergo a second review by FDA's Circulatory System Devices Panel, Robert Rudko, PhD, chairman and chief scientific officer, stated Oct. 27 at the Oppenheimer & Co. conference in New York City. Following the panel's July "not approvable" recommendation, FDA requested additional data to support a February 1997 premarket approval application. The panel called for 12 month follow-up on 200 patients ("The Gray Sheet" Aug. 4, p. 7). PLC Systems has collected the data and is preparing to submit it in November, Rudko said...
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