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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 NumberS064
Date Received02/28/2007
Decision Date05/04/2007
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 updates to the carelink v1. 1 device data management application to (1) provide support for concerto with atrial therapies; (2) allow transmission of an ?alert? signal for at/af burden and fast v response observations if there is an associated alert; (3) output the type of episode log for invalid episodes so carelink can properly display invalid episodes as arrhythmia episodes or ventricular sensing episodes; and (4) correct a problem where the cardiac compass ?ventricular rate during at/af? graph does not always print the mean ventricular rate.