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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.
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namecardiac resynchronization therapy
PMA NumberP010031
Supplement NumberS125
Date Received09/24/2008
Decision Date10/23/2008
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
Recalls CDRH Recalls
Approval Order Statement 
Approval to implement a design change to add three new "intermediate-feature" models (concerto ii model crt-d d274trk. Virtuoso ii icd model dr d274drg and model vr d274vrc) to the approved gen 2 consulta/secura/ maxima ii family of devices (consulta crt-d d224trk, maximo ii crt-d d284trk. Secure vr d224vrc, maximo ii dr d284drg, and maximo ii d284 vrc submitted under p01003i/s084 and p980016/s114, approved march 17, 2008).