|Trade Name||PHYLAX IMPLANTABLE CARDIOVERTER DIFIBRILLATOR|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Generic Name||implantable cardioverter defibrillator|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for minor mechanical changes to the ics 3000 programmer including removal of magnets from the pgh wand and replacement of an existing connector as well as associated labeling updates.