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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.
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
4 avenue reaumur
clamart cedex 92140
PMA NumberP950029
Supplement NumberS017
Date Received12/23/2002
Decision Date10/24/2003
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for new pacemaker models, symphony models 2550, and 2250 and ela rhapsody models 2530, 2510 and 2210. The symphony and ela rhapsody pacemaker systems are 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: a) symptomatic paroxysmal or permanent second- or third-degree av block; b) symptomatic bilateral bundle branch block; c) symptomatic paroxysmal or transient sinus node dysfunctions with or without associated av conduction disorders: d) bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; e) vasovagal syndromes or hypersensitive carotid sinus syndromes. In addition, the dual-chamber and atrial tracking modes (sympohony dr model 2550 and ela rhapsody dr models 2530 and 2510) are indicated for patitnes 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.