|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 MONITOR,|
|Classification Name||pulse generator, permanent, implantable|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for post sterilization test firmware, programmer application software and labeling for the devices.