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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 Namepulse generator, permanent, implantable
Generic Nametiered therapy implantable defibrillator
PMA NumberP880086
Supplement NumberS204
Date Received05/09/2011
Decision Date06/08/2011
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the new sustain xl pacemaker models, predicated off the victory/zephyr family of pacemaker. The device, as modified, will be marketed under the trade name sustain xl dr/sr and sustain xl dc/sc and is indicated for indications and usage: implantation of sustain pulse generators is indicated in 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 (models pm2134 and pm2136 only) 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 a-v block or sinus arrest 2) chronic atrial fibrillation 3) severe physical disability. Af suppression (models pm2134 and pm2136 only) is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications.