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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 FAMILIES OF CRT-ICD'S, INSYNC MAXIMO, INSYNC SENTRY FAMILY, INSYNC II PROTECT, INSYNC III MARQUIS FAMILY, INSYNC
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy
ApplicantMEDTRONIC VASCULAR
PMA NumberP010031
Supplement NumberS039
Date Received04/10/2006
Decision Date05/08/2006
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the support for the insync iii marquis to the 2490g carelink monitor and the 2491 device data management application (ddma) software, and the updates to the firmware used in the 2490g carelink monitor and updates to the 2491 ddma software.
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