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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator, pacemaker
Regulation Number870.3610
ApplicantELA MEDICAL, INC.
PMA NumberP950029
Supplement NumberS001
Date Received08/04/1998
Decision Date12/22/1998
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for functional changes to reduce size and update algorithms and features in previously approved chorus rm model 7034 and opus rm model 4534. The device, as modified, will be marketed under the trade name brio and is indicated for: the generally accepted patient conditions warranting chronic cardiac pacing which include: 1) symptomatic paroxysmal or permanent second or third-degree av block; 2) symptomatic bilateral bundle branch block; 3) symptomatic paroxysmal or transient sinus node dysfunctions with or without associated av conductions disorders; 4) bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomaitc tachyarrhythmias; and 5) vaso-vagal syndrome or hypersensitive carotid sinus syndromes. The brio 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: 1) various degrees of av block to maintain the atrial contribution to cardiac output; and 2) vvi intolerance (e. G. , pacemaker syndrome) in the presence of persistent sinus rhythm.
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