|Trade Name||EPIC/ATLAS/PROMOTE 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 |
Reduction in receiving inspection sample sizes for components used in the manufacturing of capacitors.