|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||QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS|
|Classification Name||defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)|
|Applicant||ST. JUDE MEDICAL|
|Supplement Type||normal 180 day track|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for additional assurity+, assurity, and endurity pacemakers, the allure and allure quadra cardiac resynchronization therapy pacemakers (crt-p), model 3330 version 17. 1. 1 software, and merlin pacing system analyzer (psa) model ex3100.