|Trade Name||ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD,SQ PATCH LEAD, EPICARDIAL PATCHES|
|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 an extra lead port to the the endotak sq array xp subcutaneous lead model 0049 and a modified df-1 terminal of: the endotak sq array xp subcutaneous lead model 0049; endotak sq patch lead model 0047; endotak sq array subcutaneous lead model 0049; df-1 lead adapters models 6833, 6835, 6931 and the epicardial patches models 0067, 0068, which consists of a shorter terminal pin, a counter bore in the terminal pin and a modified coil transition.