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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 NameCONCERTO,MAXIMO,CONSULTA,INSYNC SENTRY,MARQUIS,VIRTUOSO,SECURA,AND PROTECTA FAMILIES OF ICDS
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS334
Date Received08/24/2012
Decision Date09/25/2012
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 firmware updates to the model 2490c medtronic carelink remote home monitor, the model 2020a medtronic cardiosight reader, and the model 2020b carelink express monitor.
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