|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 PULSE GENERATOR|
|Classification Name||pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for updates to the home monitoring service center used with the philos ii and cylos families of pulse generators lexos and lumos families of implantable cardioverter defibrillators. Stratos lv-t pulse generator. Cardiac airbag-t and belos vr-t implantable cardioverter defibrillators, and the kronos lv-t and lumax families of implantable cardioverter defibrillators.