|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.|
|Classification Name||pulse generator, permanent, implantable|
|Generic Name||implantable pacemaker pulse generator|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the vitatron family application software models that support the diva, dema and selection afm 902 devices (vsc02 version 9. 1 sr1), c-series devices a1 models (vsf04 version 1. 3), c-series devices a3 models (vsf12 version 1. 2, and t-series devices (vsf08 version 1. 6). The modifications will update the emi behavior of your device, correct the issue of da+ inhibition of pacing below the programmed threshold, identify to the user inaccurate coulomb counts, allow the application suite to be split into several application packages, and minor software enhancements.