DevicePMAs@therightstef:P950029_S000 / 701-706
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Approval for the chorus rm model 7034 dddr pacemaker system and opus rm model 4534 ssir pacemaker system which includes an ibm compatible microcomputer which has been configured and furnished by ela medical, inc. with cso 2.46 programming software and is connected to a cpr1 programming head. These devices are indicated for: rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in minute ventilation; and the generally accepted patient conditions warranting chronic cardiac pacing which include: *symptomatic paroxysmal or permanent second or third-degreee 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 *vaso-vagal syndromes or hypersensitive carotid sinus syndromes. the chrous rm is also indicated for dual-chamber and atrial tracking modes in 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.
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