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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.
 
DeviceMEDTRONIC CONSULTA & MAXIMO ICDS
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP010031
Supplement NumberS096
Date Received04/10/2008
Decision Date07/11/2008
Product Code NIK 
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 THE INC. 3 RAMWARE, WHICH CONTAINS A DESIGN CHANGE TO ADDRESS AN ISSUE WITH THE L409 INTEGRATED CIRCUIT (IC) IN THE CONSULTA CRT-D D224TRK, MAXIMO II CRT-D D284TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH CARDIAC RESYNCHRONIZATION, SECURA DR D224DRG AND SECURA VR D224VRC, MAXIMO II DR D284DRG AND MAXIMO II VR D284VRC IMPLANTABLE CARDIOVERTER DEFIBRILLATORS.
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