|Approval Order Statement |
Approval for the aaisafer2 pacing mode and the elaview 1. 28 ug1 programming software. The device, as modified, will be marketed under the trade name symphony dr 2550 and is indicated for: 1) rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or activity. 2) the accepted patient conditions warranting chronic cardiac pacing which include, but are not restricted to: symptomatic paroxysmal or permanent second or third-degree av block, symptomatic bilateral bundle branch block, symptomatic paroxysmal or transient sinus node dysfunctions with or without associated av conduction disorders, bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias and vasovagal syndromes or hypersensitive carotid sinus syndromes. In addition, the dual-chamber and atrial tracking modes is indicated for patients who may benefit from maintenance of av synchrony. Dual-chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and av synchrony which include: various degrees of av block to maintain the atrial contribution to cardiac output and vvi intolerance (e. G. , pacemaker syndrome) in the presence of persistent sinus rhythm.