|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||ALAIR BRONCHIAL THERMOPLASTY SYSTEM|
|Classification Name||bronchial thermoplasty system|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for labeling changes to the alair catheter model ats 2-5 directions for use (dfu), alair radiofrequency (rf) controller model ats 200 operator's manual, and alair bronchial thermoplasty system patient brochure.