|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||MYCARELINK PATIENT MONITOR, DEVICE DATA MANAGEMENT APPLICATION, APPLICATION SOFTWARE|
|Classification Name||pulse generator, permanent, implantable|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for updates to the medtronic mycarelink patient monitor model 24950, reader model 24955, and accessories, model 2491 device data management application (ddma) and application software sw026 to support medtronic¿s reveal linq insertable cardiac monitors (icm).