Angeion
This article was originally published in The Gray Sheet
Executive Summary
Is in discussions with several firms regarding the potential sale of its external temporary pacemaker business. A 510(k) for the company's external pacemaker was submitted in August 1992; FDA subsequently requested additional information, which has been submitted, according to the firm. Proceeds would be used to fund the Minneapolis firm's implantable defibrillator and laser catheter projects, according to the company's third quarter (ended April 30) report. Clinical trials for the laser catheter are under way; preclinical tests with the defibrillator are continuing ("The Gray Sheet" July 20, 1992, p. 12)....