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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.
 
DeviceINSYNC MARQUIS MODEL 7277LINSYNC II MARQUIS MODEL 7289; INSYNC III MARQUIS MODEL 7279,INSYNC II PROTECT MODEL 7295; UNSY
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP010031
Supplement NumberS053
Date Received10/10/2006
Decision Date11/15/2006
Product Code NIK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE DESIGN CHANGE TO ADD ALTERNATE TANTALUM CAPACITOR (XTC018) ON THE HYBRID OF THE MEDTRONIC ICDS.
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