|Trade Name||RELIANCE IS-1 FAMILY OF LEADS|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Generic Name||transvenous defibrillation lead; accessory stylets|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for acceptance of an enhancement to the insulation and tri-lumen bond process, to include an upgrade of the bonding equipment and additional acceptance activity inspections to verify an adequate bond which will prevent fluid leakage.