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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 II PROTECT ICD, INSYNC III MARQUIS ICD,INSYNC MARQUIS ICD,INSYNC MAXIMO ICD,BRAVA CRT-D,CONCERTO ICD,CONCERTO II
Classification Namepulse generator, permanent, implantable
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS416
Date Received12/19/2013
Decision Date02/27/2014
Product Code
NVZ[ Registered Establishments with NVZ ]
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 software changes to the mycarelink patient monitor m2. 5 model 24950 with model 24955 rf head which supports the devices and medtronic¿s reveal insertable cardiac monitors models 9529, 9528 and lnq11. The mycarelink patient monitor is indicated for transmission of implantable device data to the carelink network for the clinic to review.
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