|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||pulse generator, permanent, implantable|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the model 080118 medical adhesive used as an accessory for the adapta, advisa, enrhythm, relia, sensia, and versa implantable pulse generators.