|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||implantable pacemaker pulse-generator|
|Generic Name||pulse generator|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in a controlled environmental area from class 10,000 to a minimum of class 100,000.