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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/LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T, & XELOS DR-T ICDS
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cv defibrillator/pacemaker programmer/icd monitoring system
ApplicantBIOTRONIK, INC.
PMA NumberP000009
Supplement NumberS040
Date Received06/08/2010
Decision Date11/26/2010
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
Review Memo Review Memo
Approval Order Statement 
Approval for the atrial capture control and ventricular pacing suppression features included in version 1002. U/1 programmer software for the evia/entois pulse generators.
Approval Order Approval Order
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