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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.
 
DeviceMODEL 7303 INSYNC MAXIMO DUAL CHAMBER ICD SYSTEM AND MODEL 9998 APPLICATION SOFTWARE VERSION 1.0 FOR THE MODEL 2090 PROG
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 NumberS013
Date Received05/10/2004
Decision Date06/23/2004
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
MODEL 7303 INSYNC MAXIMO DUAL CHAMBER ICD SYSTEM AND MODEL 9998 APPLICATION SOFTWARE VERSION 1.0 FOR THE MODEL 2090 PROGRAMMER SYSTEM.
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