|Trade Name||ENDOTAK RELIANCE G/SG LEAD MODELS 0180-0187|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Generic Name||transvenous defibrillation lead; accessory stylets|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for addition of an eptfe coating to the shock coils. The device, as modified, will be marketed under the trade name endotak reliance g/sg lead models and is indicated for providing pacing and rate-sensing and to deliver cardioversion and defibrillation shocks for icd automatic implantable cardioverter defibrillator systems.