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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceALAIR BRONCHIAL THERMOPLASTY SYSTEM
Generic NameBronchial thermoplasty system
ApplicantBoston Scientific Corp.
888 ROSS DRIVE
SUITE 100
SUNNYVALE, CA 94089
PMA NumberP080032
Date Received12/30/2008
Decision Date04/27/2010
Product Code OOY 
Docket Number 10M-0242
Notice Date 05/19/2010
Advisory Committee Anesthesiology
Clinical TrialsNCT00231114
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ALAIR BRONCHIAL THERMOPLASTY SYSTEM. THE DEVICE IS INDICATED FOR THE TREATMENT OF SEVERE PERSISTENT ASTHMA IN PATIENT 18 YEARS AND OLDER WHOSE ASTHMA IS NOT WELL CONTROLLED WITH INHALED CORTICOSTEROIDS AND LONG ACTING BETA AGONISTS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S016  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S017 S018 S019 S020 
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