|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 ICD MODELS (E050, E051, E052, E052), ENERGEN ICD MODELS (E140, E141, E142, E143) INCEPTA ICD MODELS (E160, E161,|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Supplement Type||real-time process|
|Supplement Reason|| design change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for minor design changes and associated manufacturing changes to the punctua/ incepta/ energen hybrid assembly.