|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Changes to the molds used in the manufacture of the devices and the addition of a second supplier of these molds.