|Trade Name||MEDTRONIC INSYNC BIVENTRICULAR PACING SYSTEM|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| postapproval protocol or modification to a protocol|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval of the post-approval study for the device. The post-approval study has been submitted to comply with the conditions of approval outlined in the august 28, 2001 approval order for p010015.