|Trade Name||MEDTRONIC MODEL 2490D CARELINK MONITOR|
|Classification Name||implantable pacemaker pulse-generator|
|Generic Name||pulse generator|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the model 2490d carelink monitor and model 2491 ddma software to allow their use with enpulse and kappa devices. 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.