|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||MEDTRONIC KAPPA 700/600 PACING SYSTEM WITH MODEL 9953-SERIES 1.1 SOFTWARE|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the medtronic. Vision software models 9953 and 9953a (series 1. 3) for use with the medtronic model 9790 programmers to program the medtronic kappa 700 series pacemakers. The device, as modified, will be marketed under the trade name medtronic. Vision software models 9953/9953a and is indicated for use with the medtronic kappa 700 series pacemakers to allow electrophysiology stimulation (eps) functions.