|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||PROMOTE, PROMOTE+, PROMOTE ACCEL AND UNIFY CRT-D'S AND LEADS AND MERLIN PROGRAMMER|
|Classification Name||defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)|
|Applicant||ST. JUDE MEDICAL|
|Supplement Type||real-time process|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a labeling change from sj-4 to df-4 for st. Jude medical high voltage lead, implantable cardioverter-defibrillator (icd) and cardiac resynchronization therapy defibrillator (crt-d) products.