|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||CARELINK MONITORS, CARELINK EXPRESS MONITIORS, CARDIOSIGHT READERS, REVEAL DX, REVEAL XT|
|Classification Name||pulse generator, permanent, implantable|
|Supplement Type||real-time process|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for cellular connectivity for remote monitoring with model 2020a cardiosight reader and models 2020b, 2020c medtronic carelink express monitors.