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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 pulse generator programming software
Regulation Number870.3610
PMA NumberP980035
Supplement NumberS030
Date Received06/05/2003
Decision Date12/18/2003
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for enpulse implantable pulse generator and model 9991 application software. The device, as modified, will be marketed under the trade name enpulse ipg and is indicated as follows: enpulse pacemakers are indicated for use in patients who are experiencing accepted 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 conduction disorders. 4) bradycardia-tachycardia syndrome. 5) vasovagal syndromes or hypersensitive carotid sinus syndromes. Enpulse pacemakers are also indicated for use in patients who may benefit from rate responsive pacing to support cardiac output during varying levels of activity. Using rate response modes may restore heart rate variability by improving cardiac output. These devices are also indicated for use in patients who may benefit from maintenance of av synchrony through the use of dual chamber modes and atrial tracking modes. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and av synchrony. Dual chamber modes are indicated for use in patients who have experienced one or both of the following conditions: 1) various degrees of av block 2) vvi intolerance (for example, pacemaker syndrome) in the presence of persistent sinus rhythm. This device is also indicated for vdd pacing in patients who have adequate rates and one or both of the following conditions: 1) a requirement for ventricular pacing when adequate atrial rates and adequate intracavitary atrial complexes are present. This includes the presence of complete av block when atrial contribution is needed for hemodynamic benefit or when pacemaker syndrome had existed or is anticipated. 2) a requirement for intermittent ventricular pacing despite a normal sinus rhythm and normal.