|
Device | ALAIR BRONCHIAL THERMOPLASTY SYSTEM |
Generic Name | Bronchial thermoplasty system |
Applicant | Boston Scientific Corp. 888 ROSS DRIVE SUITE 100 SUNNYVALE, CA 94089 |
PMA Number | P080032 |
Date Received | 12/30/2008 |
Decision Date | 04/27/2010 |
Product Code |
OOY |
Docket Number | 10M-0242 |
Notice Date | 05/19/2010 |
Advisory Committee |
Anesthesiology |
Clinical Trials | NCT00231114
|
Expedited Review Granted? | Yes |
Combination Product | No |
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 |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 |