|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||ADVISA MRI (A2DR01)|
|Classification Name||pulse generator, permanent, implantable|
|Generic Name||pulse generator, permanent, implantable|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Elimination of the incoming inspection of a battery component at an internal supplier location; reduction in production burn-in time; and an update to the battery burn-in process and inspection methods and associated software.