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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 NameBELOS A+ AND BELOS A+/T ICD AND KAINOX A+ ICD LEAD (SINGLE-LEAD SYSTEM)
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cv defibrillator/pacemaker programmer/icd monitoring system
ApplicantBIOTRONIK, INC.
PMA NumberP000009
Supplement NumberS009
Date Received07/03/2003
Decision Date11/13/2003
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 the lexos family of implantable cardioverter defibrillators (icds) and software modifications to the belos family of icds, the cardiac airbag-t and the microphylax icd. The new device will be marketed under the trade name lexos vr, lexos vr-t, lexos dr, lexos dr-t implantable cardioverter defibrillators and programmer software (a-k00. 1. U/4).
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