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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 NameCONSULTA CRT D, MAXIMO II CRT-D, CONCERTO II CRT -D, CONCERTO CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA XT CRT-D, V
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS394
Date Received08/12/2013
Decision Date10/15/2013
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a firmware update to version cm2490c_10v5 for the model 2490c carelink remote home monitor and for a firmware update to version cm2490g_14v2 for the 2490g medtronic carelink remote home monitor, model 2020a cardiosight reader, and 2020b carelink express monitor for the devices.
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