|Trade Name||RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Generic Name||implantable cardioverter defibrillator (non-crt)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| other report|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a supplement which satisfies the requirement to submit a post-approval study protocol for the intermedics epicardial patch defibrillation leads. The post approval study was required as a conidtin of approval in our letter dated november 7, 1995.