|Trade Name||EPIC HF FAMILY CRT-D'S|
|Classification Name||defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)|
|Applicant||ST. JUDE MEDICAL|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following modifications: 1) replace the existing hand solder interconnections between subassemblies with plug/receptacle connectors; 2) an organic substrate will be used for the hybrid module; and 3) discrete surface mount magnetic components were re-configured into surface-mountable packages.