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St. Jude Response CV

This article was originally published in The Gray Sheet

Executive Summary

Market launch of the cardioversion catheter system, approved via PMA May 7, will await supplemental approval of an updated power source, according to St. Jude Medical. The advanced version already is available in Europe. The system, which includes a cardioversion electrophysiology catheter and cable, extension cable and switchbox, is indicated for "invasive evaluation of cardiac arrhythmias and can be used for intracardiac cardioversion of atrial tachyarrhythmias" when connected to a compatible cardioverter defibrillator and EP recording system, FDA says...
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