|Trade Name||ENDOTAK RELIANCE LEADS|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Generic Name||transvenous defibrillation lead; accessory stylets|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the manufacturing process that adds a drug collar inspection to the assembly and bonding manufacturing instruction for the leads.