|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||VIVA CRT-P,CONSULTA CRT-P,SYNCRA CRT-P|
|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 the medtronic viva crt-p model c6tr01 implantable pacemaker with cardiac resynchronization; programmer software application model 9995 v8. 3; and updates to the medtronic carelink monitor model 2490g, cardiosight reader model 2020a and carelink express model 2020b firmware, and to the model 2491 device data management application (ddma).