|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||PUNCTUA,TELIGEN,ENERGEN,INCEPTA,VITALITY ICDS|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Generic Name||implantable pulse generator, pacemaker (non-crt)|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Add instructions for cleaning the seal plug bond area of the polyurethaneheaders of the above referenced devices to the appropriate work instructions.