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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameALAIR BRONCHIAL THERMOPLASTY SYSTEM
Classification Namebronchial thermoplasty system
ApplicantBOSTONSCIENTIFIC
PMA NumberP080032
Supplement NumberS010
Date Received10/11/2012
Decision Date11/09/2012
Product Code
OOY[ Registered Establishments with OOY ]
Advisory Committee Anesthesiology
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product 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.
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