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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBELOS A+ AND BELOS A+/T ICD AND KAINOX A+ ICD LEAD (SINGLE-LEAD SYSTEM)
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP000009
Supplement NumberS009
Date Received07/03/2003
Decision Date11/13/2003
Product Code MRM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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