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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceALAIR BRONCHIAL THERMOPLASTY SYSTEM
Generic NameBronchial thermoplasty system
ApplicantBoston Scientific Corp.
888 ROSS DRIVE
SUITE 100
SUNNYVALE, CA 94089
PMA NumberP080032
Supplement NumberS010
Date Received10/11/2012
Decision Date11/09/2012
Product Code OOY 
Advisory Committee Anesthesiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
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.
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