DVI AtheroCath-GTO U.S. sales to resume following approval of PMA supplement.
This article was originally published in The Gray Sheet
Executive Summary
DVI ATHEROCATH-GTO U.S. MARKETING WILL RESUME FOLLOWING FDA APPROVAL of a premarket approval application supplement covering modifications made to the device, the company said. Until FDA approves the recently filed supplement, Devices for Vascular Intervention will be selling an earlier generation atherectomy device, the AtheroCath SCA-EX. The SCA-EX has continued to be available since the full market release of the GTO in September 1994.