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Eclipse TMR Laser Gains Panel Approval Despite 5% Overall Mortality Rate

This article was originally published in The Gray Sheet

Executive Summary

Eclipse Surgical should meet with FDA to develop a postmarket study for the Eclipse 2000 transmyocardial revascularization laser system for treatment of patients with Class IV angina refractory to medical treatment, FDA's Circulatory System Devices Panel concluded at an Oct. 27 meeting.

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US FDA Still Seeking Sponsor Cooperation For Oncology Label Updates

Oncology Center of Excellence is reviewing a research report on fluorouracil, and will next look to update cisplatin's label, but eventually must convince the reference product sponsor to submit the changes.

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