|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||CONSULTA CRT-P,SYNCRA CRT-P|
|Classification Name||pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for software changes to the mycarelink patient monitor m2. 5 model 24950 with model 24955 rf head which supports the devices and medtronic¿s reveal insertable cardiac monitors models 9529, 9528 and lnq11. The mycarelink patient monitor is indicated for transmission of implantable device data to the carelink network for the clinic to review.