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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 NameTACHOS ATX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND PROGRAMMER SOFTWARE
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cv defibrillator/pacemaker programmer/icd monitoring system
ApplicantBIOTRONIK, INC.
PMA NumberP000009
Supplement NumberS007
Date Received12/19/2002
Decision Date05/29/2003
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the tachos dr atrial tx implantable cardioverter defibrillator system. The device, as modified, will be marketed under the trade name, tachos atx and is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening arrhythmias. The device is indicated for use in icd patients either with atrial tachyarrhythmias or who are at risk of developing atrial tachyarrhythmias.
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