|Trade Name||MEDTRONIC INSYNC MAXIMO MODEL 7304 AND MODEL 7303|
|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 - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the carelink monitor model 2490g for use with additional pulse generator models, specifically the insync sentry model 7299, insync maximo model 7304, and the v-v timing feature for both the insync sentry model 7297 and the insync maximo model 7303. The carelink system is indicated for use by a patient to interrogate their implanted device, and transfer the data to a private, secure server by use of a standard (analog) telephone connection.