|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.|
|Trade Name||STRATOS LV AND LV-T PULSE GENERATORS|
|Classification Name||pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for: 1) commercial distribution of the lumax hf-t crt-ds and stratos lv (-t) crt-ps with ventricle to ventricle (v-v) delay features; and 2) updated model ics 3000 programmer software (release of 802. U/2) to implement the v-v delay features and other minor enhancements.