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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 DR ATRIAL TX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD SYSTEM
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cv defibrillator/pacemaker programmer/icd monitoring system
ApplicantBIOTRONIK, INC.
PMA NumberP000009
Supplement NumberS004
Date Received03/22/2002
Decision Date09/09/2002
Product Code
MRM[ Registered Establishments with MRM ]
Docket Number 07M-0408
Notice Date 11/09/2007
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the tachos dr atrial tx implantable cardioverter defibrillator (icd) system, model 122499 with software cartridge swm / i-kdr. 0. C, model 339684. The device is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The device is indicated for use in icd patients with either atrial tachyarrhythmias or who are at risk of developing atrial tachyarrhythmias.
Approval Order Approval Order
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