|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, TELIGEN, ENERGEN AND PUNCTUA ICD DEVICES|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an alternate supplier for the unfiltered feedthru.