Guidant Ventak Prizm 2
This article was originally published in The Gray Sheet
Executive Summary
First implants of the 32 cc, 12 mm wide automatic, dual-chamber cardioverter defibrillator/pacemaker take place at the Leiden University Medical Center in The Netherlands and at the Herzzentrum Nordrhein-Westfalen in Bad Oeynhausen, Germany. At the time of FDA's Aug. 8 approval of the device via PMA supplement, Guidant said that it planned to follow 30 patients for 30 days prior to a full-scale worldwide launch in mid-October (1"The Gray Sheet" Aug. 14, 2000, p. 9)