|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 VISION SOFTWARE SERIES 4.0|
|Generic Name||dual chamber implantable cardioverter defibrillator system|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the programming software to be used with the medtronic gem dr (model 9960 software), gemii vr (model 9965 software), and gem ii dr (model 9964 software) icd systems. The device, as modified, will be marketed under the trade name of medtronic vision software series 4. 0.