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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 NameLUMAX 540 VR-T DX ICD
Classification Namedefibrillator, implantable, dual-chamber
ApplicantBIOTRONIK, INC.
PMA NumberP050023
Supplement NumberS029
Date Received03/02/2010
Decision Date04/30/2010
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for introduction of the lumax 540 vr-t dx implantable cardioverter defibrillator (icd), a single lead icd system used in conjunction with the currently approved kainox a+ icd lead. The device, as modified, will be marketed under the trade name lumax 540 vr-t dx icd and is indicated for providing ventricular antitachycardia pacing and ventricular defibrillation, for automated treatment of life threatening ventricular arrhythmias.
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