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In Brief: PLC Systems Heart Laser

This article was originally published in The Gray Sheet

Executive Summary

PLC Systems Heart Laser: Firm submits to FDA 12-month follow-up data for its transmyocardial revascularization device in response to a request by FDA's Circulatory System Devices Panel in its review of the firm's premarket approval application in July ("The Gray Sheet" Aug. 4, p. 7). The panel voted 9-2 to recommend against approval of the device due to lack of follow-up data. PLC expects to provide FDA with additional data by the end of the year. If approved, the system would be the first treatment for patients who do not respond to direct coronary revascularization to reach the U.S. market...
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