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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 MARQUIS DR 7274.MARQUIS VR 7230,MAXIMO DR 7278,MAXIMO VR 7232
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MS MVS11
MOUNDS VIEW, MN 55112
PMA NumberP980016
Supplement NumberS038
Date Received10/07/2003
Decision Date10/23/2003
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 BATTERY CHANGES TO THE CHI 4420L BATTERY IN THE MEDTRONIC MARQUIS DR MODEL 7274, MARQUIS VR MODEL 7230, MAXIMO DR MODEL 7278, MAXIMO VR MODEL 7232, INSYNC MARQUIS MODEL 7277 AND THE INSYNC II MARQUIS MODEL 7289.
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