|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 III MODEL 2033B & DIALOG II MODEL 2037B|
|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 relocating the manufacturing facilities to 15900 valleyview court, sylmar, ca. , 91392-9221.