DevicePMAs@therightstef:P950037_S084 JSONTXT 13 Projects

Approval for two new families of temporary external pacemaker pulse generators. New features include: 1) redel pacing wire connection adapters; 2) trigger modes vt and sst; 3) sensitivity settings up to 20 mv for the reocor s model; and 3) programmable av delay up to 400 ms. The device, as modified will be marketed under the trade names reocor s and reocor d and is indicated for: temporary pacing; temporary treatment of arrhythmias and heart block; symptomatic sinus bradycardia; pre-, intra-, and postoperative temporary stimulation of patients undergoing cardiac surgery; termination of supraventricular tachyarrhythmias; prophylactic pacing for prevention of arrhythmias; emergency pacing; and checking pacing thresholds.