|Trade Name||VITATRON DA+ C SERIES PULSE GENERATORS|
|Classification Name||implantable pacemaker pulse-generator|
|Generic Name||implantable pacemaker pulse generator programming software|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to rate response features, addition of telemetry b, and other diagnostic enhancements. The device, as modified, will be marketed under the trade name medtronic/vitatron da+ c-series implantable generators and is indicated as follows: 1) dual chamber pacing is indicated if av synchrony needs to be restored in order to optimize cardiac output. For example, patients with symptomatic second or third degree av block. 2) dual chamber rate responsive pacing modes are of specific benefit to patients with chronotropic incompetence of the sinus node. 3) rate responsive modes can help patients who have a requirement for an increase in pacing rate in response to physical activity. 4) single chamber ventricular pacing can help patients with permanent atrialtachyarrhythmias, including atrial fibrillation and flutter. 5) single chamber atrial pacing can help patients with symptomatic bradyarrhythmias and normal av conduction.