|Trade Name||ENDOTAK FAMILY OF ENDOCARDIAL DEFIBRILLATION LEAD MODELS|
|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 - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a modified df-1 terminal of the endotak(r) series of endocardial defibrillation leads and the model 6952 lead extender, which consists of a shorter terminal pin, a counter bore in the terminal pin, and a modified coil transition.