|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||MEDTRONIC SIGMA/MEDTRONIC 350 SERIES PULSE GENERATORS PRODUCTS|
|Generic Name||implantable pulse generator programming software|
|Supplement Type||normal 180 day track|
|Supplement Reason|| location change: manufacturer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for alternate manufacturing, packaging and sterilization facilities at medtronic bv, the netherlands and medtronic europe s. A. , tolochenaz, switzerland.