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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameINSYNC MARQUIS MODEL 7277 AND THE INSYNC II MARQUIS MODEL 7289
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy
ApplicantMEDTRONIC VASCULAR
PMA NumberP010031
Supplement NumberS010
Date Received10/09/2003
Decision Date10/23/2003
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
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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