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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
St. Jude Medical, Inc.
15900 valley view court
sylmar, CA 91342
PMA NumberP880086
Supplement NumberS083
Date Received03/08/2001
Decision Date07/11/2001
Product Code
DXY[ Registered Establishments with DXY ]
Docket Number 01M-0462
Notice Date 10/11/2001
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the integrity afx dr model 5346 pulse generator and programmer software model 3307, v2. 2a. The device is indicated for use in patients with the following permanent conditions, when associated with symptoms including, but not limited to: 1)syncope 2) presyncope 3) fatigue 4) disorientation 5) or any combination of those symptoms. Rate-modulated pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-chamber pacing is indicated for those patients exhibiting: 1) sick sinus syndrome 2) chronic, symptomatic second- and third degree av block 3) recurrent adams-stokes syndrome 4) symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out. Atrial pacing is indicated for patients with sinus node dysfunction and normal av and intraventricular conduction systems. Ventricular pacing is indicated for patients with significant bradycardia and: 1) normal sinus rhythm with only rare episodes of av block or sinus arrest 2) chronic atrial fibrillation 3) severe physical disability. Dynamic atrial overdrive is indicated for suppression of atrial tachyarrhythmias including paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling