|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 Name||implantable pacemaker pulse-generator|
|Generic Name||implantable pacemaker pulse-generator|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a name change of the approved actros pulse generator family to the actros+ pulse generator family. The device, which has not been modified, will be marketed under the trade name actros+ and is indicated for patients exhibiting chronotropic incompetence and who would benefit from increase pacing rates concurrent with physical activity. Generally accepted indications for long-term cardiac pacing inlcude, but are not limited to:sick sinus syndrom (i. E. , bradycardia-tachycardia syndrome, sinus arrest, sinus bradycardia), sino-atrial(sa) block, second- and third- degree av block and carotid sinus syndrome. Patients who demonstrate hemodynamic benefit through maintenance of av synchrony should be considered for one of the dual-chamber or atrial pacing modes. Dual-chamber modes are specifically indicated for treatment of conduction disorders that require both resoration of rate and av synchrony such as av nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing.