|Trade Name||EPIC HF/ATLAS+ HF FAMILY OF CRT-DS|
|Classification Name||defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)|
|Applicant||ST. JUDE MEDICAL|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Changes to the limits for a device level manufacturing test as well as the addition of in-process verification tests.