ALAIR BRONCHIAL THERMOPLASTY SYSTEM

Bronchial Thermoplasty System

FDA Premarket Approval P080032 S010

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

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.

DeviceALAIR BRONCHIAL THERMOPLASTY SYSTEM
Classification NameBronchial Thermoplasty System
Generic NameBronchial Thermoplasty System
ApplicantBoston Scientific Corp.
Date Received2012-10-11
Decision Date2012-11-09
PMAP080032
SupplementS010
Product CodeOOY
Advisory CommitteeAnesthesiology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corp. 888 Ross Drive suite 100 sunnyvale, CA 94089

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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