|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/LV-T|
|Classification Name||pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a software upgrade to version 902. U/1. This software is used in the ics 3000 system to program and interrogate all of biotronik¿s us market released bradycardia and tachycardia pacemakers.