|Trade Name||CONCERTO MODELS C154DWK / C164AWK CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS|
|Classification Name||defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)|
|Generic Name||cardiac resynchronization therapy|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| 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.