|Trade Name||ADVISA MRI|
|Classification Name||pulse generator, permanent, implantable|
|Generic Name||implantable pulse generator|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Multiple manufacturing changes previously accepted for other market released medtronic devices, which included: 1) cmos process flow changes at your supplier; 2) updates to the test software and hardware for integrated circuits; 3) addition of high temperature monitoring to the high power lean line; 4) update to a manufacturing assembly controller system; 5) implementation of a new cleaning process and curing oven; and 6) and implementation of the manufacturing execution system version 7. 9 at various internal suppliers and final device manufacturing locations.