|Trade Name||EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD|
|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 |
A new laser welding station for the battery electrical connection process as well as a change in manufacturing location for the laser welding process and open circuit voltage inspection (ocv).