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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/DR (-T) AND LEXOS DR/VR (-T) ICD'S
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP000009
Supplement NumberS025
Date Received01/15/2008
Decision Date03/10/2008
Product Code MRM 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO: 1) GEOMETRICAL DIMENSIONS OF THE FLANGE OF THE FEEDTHROUGH; AND 2) INSULATING GLASS TYPE 8455 HAS BEEN REPLACED BY GLASS TYPE 8250.
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