|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||SENSOLOG(R) CARDIAC PACING SYSTEM|
|Classification Name||implantable pacemaker pulse-generator|
|Supplement Type||normal 180 day track|
|Supplement Reason|| location change: manufacturer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an alternative sterilization cycle and a new sterilization site at the solna, sweden, manufacturing site.