|Trade Name||ENDOTAK RELIANCE G/SG 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 manufacturing process that improves the distal coil bonding process by 1) changing the constitution of the bonding adhesive, 2) changing the tool used to apply the bonding adhesive, and 3) adding diagrams to the manufacturing instructions for the leads.