|Trade Name||ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Generic Name||nonthorocotomy leads for cardioverter|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a design change to provide higher pacing impedance. Teh device, as modified, will be marketed under the trade name endotak(r) endurance(tm) endocardial defibrillation lead and is indicated for use to provide pacing and rate-sensing and delivery cardioversiona nd defibrillation shocks for aicd automatic implantable cardioverter defibrillator systems.