DevicePMAs@therightstef:P930022_S000 JSONTXT 9 Projects

Approval for the legend plus(r) pacing system including the legend plus(r) pulse generator models 8446 and 8448; the model 9790 and 9790c programmers with the model 9891 baseline software and with the mode 9807 software. this system is indicated for permanent ventricular or atrial pacing applications. Its use is indicated in the treatment of patients who may benefit from a pcing rate that chagnes in response to activity. Ventricular indications include: 1)chronic atrial flutter or fibrillation with slow ventricular response; 2)sinus node dysfunctions or sick sinus syndrome (e. g., sinus bradycardia, sinus arrest and/or exit block, bradycardiatachycardia syndrome, chronotropic insufficiency, etc.,); and 3)av block. Atrial indications include: 1)sinus node dysfunction or sick sinus syndrome (e. g., sinus bradycardia, sinus arrest and/or exit block, bradycardiatachycardia syndrome, etc.,) with intact av conduction