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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 NameTALENT II DUAL-SENSOR IMPLANTABLE CARDIAC PACEMAKERS, MODELS DR233 AND SR133
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable rate-responsive cardiac pacemaker & programmer
Regulation Number870.3610
ApplicantELA MEDICAL, INC.
PMA NumberP950029
Supplement NumberS016
Date Received07/11/2002
Decision Date12/18/2002
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 the addition of the autosensing feature. The device, as modified, will be marketed under the trade name talent ii, models dr233 and sr133, and is indicated for rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or activity. The accepted patient conditions warranting chronic cardiac pacing 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 conduction disorders; 4) bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; 5) vasovagal syndromes or hypersensitive carotid sinus syndromes. The model dr233 is also indicated for dual-chamber and atrial tracking modes in patients whom 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; 2) vvi intolerance (e. G. , pacemaker syndrome) in the presence of persistent sinus rhythm.
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