|Trade Name||EVERA S DR, EVERA S VR, EVERA XT DR|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
The implementation of factory works release 8. 0 and mes web services release 2. 1; 2) the approval of manufacturing lines in a new extension of a controlled environment area; 3) new pressure test equipment to verify hermeticity; 4) modifications to a controlled environment; 5) a change to the descum and cleaning process for the 3um cmos integrated circuit; and 6) a new software version for process data collection software at a medtronic supplier.