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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 Namedefibrillator, implantable, dual-chamber
Generic Namedefibrillator, implantable, dual-chamber
6024 jean road
lake oswego, OR 97035
PMA NumberP000009
Supplement NumberS020
Date Received09/11/2006
Decision Date12/07/2006
Product Code
MRM[ Registered Establishments with MRM ]
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 lumax implantable cardioverter defibrillators (icds), models 300 vr, 340 vr, 300 vr-t, 340 vr-t, 300 dr, 340 dr, 300 dr-t, 340 dr-t, 300 hf, 340 hf, 300 hf-t and 340 hf-t and programmer software version 603. U for use with the lumax family of icds and biotronik, inc. Pacers, single chamber icds and dual chamber icds. The device, as modified, will be marketed under the trade name lumax, and is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias and/or for providing treatment of congestive heart failure.