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In Brief: DVI Atherocath-GTO

This article was originally published in The Gray Sheet

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Executive Summary

DVI Atherocath-GTO: Devices for Vascular Intervention resumes shipment of the atherectomy catheter after receiving approval of a PMA supplement for modifications made to the device. The Guidant unit halted shipments of the GTO on May 17 after it was notified by FDA that approval of the changes was required. The company says it will continue to ship the AtheroCath SCA-EX, an earlier version atherectomy catheter that was being sold in place of the GTO...

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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