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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 NumberS016
Date Received06/01/2015
Decision Date12/29/2015
Product Code OOY 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR DESIGN CHANGE TO THE ALAIR RF CONTROLLER TO REPLACE AN OBSOLETE COMPONENT THAT IS NO LONGER COMMERCIALLY AVAILABLE.
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