|Trade Name||SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Changes related to manufacturing process of the battery including qualifying a new weld machine, modifying the insulating tape used in shipping, and new fixtures.