ALAIR BRONCHIAL THERMOPLASTY SYSTEM

Bronchial Thermoplasty System

FDA Premarket Approval P080032

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.

Pre-market Approval Supplement Details

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.

DeviceALAIR BRONCHIAL THERMOPLASTY SYSTEM
Classification NameBronchial Thermoplasty System
Generic NameBronchial Thermoplasty System
ApplicantBoston Scientific Corp.
Date Received2008-12-30
Decision Date2010-04-27
Notice Date2010-05-19
PMAP080032
SupplementS
Product CodeOOY
Docket Number10M-0242
Advisory CommitteeAnesthesiology
Expedited ReviewYes
Combination Product No
Applicant Address Boston Scientific Corp. 888 Ross Drive suite 100 sunnyvale, CA 94089
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P080032Original Filing
S020 2021-10-28 30-day Notice
S019
S018 2021-04-30 30-day Notice
S017 2017-11-29 135 Review Track For 30-day Notice
S016 2015-06-01 Normal 180 Day Track
S015 2014-03-14 Normal 180 Day Track No User Fee
S014 2013-11-05 30-day Notice
S013 2013-03-14 Normal 180 Day Track No User Fee
S012 2012-12-26 Normal 180 Day Track
S011 2012-11-15 30-day Notice
S010 2012-10-11 Special (immediate Track)
S009 2012-02-14 Normal 180 Day Track No User Fee
S008 2012-02-21 30-day Notice
S007 2011-06-03 Normal 180 Day Track No User Fee
S006 2011-02-11 Normal 180 Day Track No User Fee
S005 2010-11-08 Normal 180 Day Track No User Fee
S004 2010-08-13 Normal 180 Day Track
S003 2010-08-02 30-day Notice
S002 2010-05-28 Normal 180 Day Track No User Fee
S001

NIH GUDID Devices

Device IDPMASupp
08714729802822 P080032 000
08714729802792 P080032 000
08714729802778 P080032 000
08714729796695 P080032 000
08714729961154 P080032 016

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