|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||EVERA S DR, EVERA S VR, EVERA XT DR, EVERA XT VR|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Seven previously approved manufacture changes for the devices. Those are: 1) update the cmos ic process flow changes at your supplier; 2) update the test software and hardware on the teradyne test platform for m019 and m017 ics; 3) add the high temperature monitor to high power lean line; 4) update the automated assembly equipment controller (aaec); 5) implement a new cleaning process and a curing oven; 6) implement a manufacturing execution system version 7. 9 at various internal suppliers and final device manufacturing locations; and 7) update to the test system software shell.