|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||VITATRON(R) DEMA PACING SYSTEM|
|Classification Name||implantable pacemaker pulse-generator|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the dema pacing system and the citatron application software model vsa02, version 6. The dema pacing system consists of the following pulse generators: clarity ddr models 860, 862, 865; clarity ssir models 560, 562, 565; diamond 3 model 840; ruby 3 model 740; topaz 3 model 540; jade 3 model 340; vita 2 ddr model 830; vita 2 model 530.