|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||INCEPTA, ENERGEN AND PUNTUA IDCS|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Implementation of a new acceptance methodology at the quality system level.