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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.
 
DeviceCARDIAC AIRBAG-T AND BELOS VR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS035
Date Received10/31/2008
Decision Date11/21/2008
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR UPDATES TO THE HOME MONITORING SERVICE CENTER USED WITH THE PHILOS II AND CYLOS FAMILIES OF PULSEGENERATORS LEXOS AND LUMOS FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS. STRATOS LV-TPULSE GENERATOR. CARDIAC AIRBAG-T AND BELOS VR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND THE KRONOS LV-T AND LUMAX FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
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