|Trade Name||MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE|
|Classification Name||implantable pacemaker pulse-generator|
|Generic Name||pulse generator|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Requested a change in the application pattern of the epoxy area that affixes the device battery to the insulator cup, and an epoxy bead or fillet will be added between the battery and the hybrid.