|Trade Name||SYNERGYST II MEDTRONIC MODEL 9889E SOFTWARE|
|Classification Name||implantable pacemaker pulse-generator|
|Generic Name||pulse generator|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to market software (model 9889e) which is designed to provide programming capabilities, using the already approved 9790 and 9790a programmers for three models of pulse generators as relabeled for distribution by another company, cpi under their trade names. The pacemakers are: the legend to be relabeled as triumph vr, elite to be relabeled as prelude dr and synergyst ii to be relabeled as triumph dr.