|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-T|
|Classification Name||pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)|
|Supplement Type||real-time process|
|Supplement Reason|| design change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a diode change in the stratos lv and lv-t crt-ps. The device, as modified, will be marketed under the trade name stratos lv crt-p and stratos lv-t crt-p and is indicated for treatment of bradycardia in heart failure patients.