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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 NameZEPHYR PULSE GENERATORS MODELS XL DR 5826,DR5820 & SR 5620
Classification Namepulse generator, permanent, implantable
Generic Nametiered therapy implantable defibrillator
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP880086
Supplement NumberS139
Date Received12/12/2006
Decision Date03/29/2007
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the zephyr pulse generators models: xl dr 5826, dr 5820 and sr 5620. The device is indicated in the following permanent conditions, when associated with symptoms including, but not limited to: syncope, presyncope, fatigue, disorientation, 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 5826, 5820 only) is indicated for those patients exhibiting: sick sinus syndrome, chronic symptomatic second- and third-degree av block, recurrent adams-stokes syndrome, or 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: normal sinus rhythm with only rare episodes of a-v block or sinus arrest, chronic atrial fibrillation, severe physical disability. Af suppression (models 5826, 5820 only) is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications.
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