|Trade Name||CONTAK TR CARDIAC RESYNCHRONIZATION THERAPY SYSTEMS|
|Classification Name||pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)|
|Generic Name||cardiac resynchronization therapy pacemaker (crt-p)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for product reliability test to be added to the physician and patient labeling as well as other minor changes to the patient manuals.