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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameALAIR BRONCHIAL THERMOPLASTY SYSTEM
Classification Namebronchial thermoplasty system
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP080032
Date Received12/30/2008
Decision Date04/27/2010
Product Code
OOY[ Registered Establishments with OOY ]
Docket Number 10M-0242
Notice Date 05/19/2010
Advisory Committee Anesthesiology
Clinical Trials NCT00231114
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH 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 Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 
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