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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 II CRT-D MODELS C154DWK, C164AWK
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy
Applicant MEDTRONIC INC.
PMA NumberP010031
Supplement NumberS126
Date Received09/26/2008
Decision Date10/21/2008
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to implement a design change to use models 2490c medtronic carelink monitor, 2020a cardiosight reader, and 2491 device data management application (ddma) to provide patients and data transfer for the concerto ii model crt-d d274trk, virtuoso ii icd model dr d274drg and model vr d274vrc devices.
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