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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.
 
DeviceLUMOS VR-T AND LUMOS DR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH 502.U ICS PROGRAMMER SOFTWARE, A-K00.4.U EPR/...
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP000009
Supplement NumberS016
Date Received06/16/2005
Decision Date08/11/2005
Product Code MRM 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO IMPLEMENT INTRACARDIAC ELECTROGRAM (IEGM) SNAPSHOTS OF TACHYCARDIA EVENTS INTO HOME MONITORING TRANSMISSIONS. IN ORDER TO ACCOMPLISH THIS, YOU HAVE REQUESTED THE APPROVAL OF THE LUMOS FAMILY OF ICDS PROGRAMMER SOFTWARE UPGRADES, AND AN UPGRADE TO THE CURRENTLY MARKETED HOME MONITORING SERVICE CENTER.
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