|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||INSYNC; INSYNC III; ATTAIN LEAD; ATTAIN OTW LEAD|
|Classification Name||pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| labeling for post approval study|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a labeling update to include the results from the post-approval study, specifically the medtronic insync registry post approval study.