|Trade Name||LEAD ADAPTERS MODEL NUMBER 6024|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Generic Name||transvenous defibrillation lead; accessory stylets|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the supplier that provides the mold release coating that is used on the sleeve of the lead adapters to prevent the bonding of the silicon sleeve to itself.