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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator, pacemaker
Regulation Number870.3610
PMA NumberP950029
Date Received08/02/1995
Decision Date03/10/1997
Product Code
DXY[ Registered Establishments with DXY ]
Docket Number 97M-0185
Notice Date 05/19/1997
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
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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