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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 Dr.
Suite100
Sunnyvale, CA 94089
PMA NumberP080032
Supplement NumberS008
Date Received02/21/2012
Decision Date03/22/2012
Product Code OOY 
Advisory Committee Anesthesiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
PROCESS CHANGES RELATED TO THE ALAIR CATHETER MODEL AS WELL AS THE ALAIR RADIOFREQUENCY CONTROLLER.
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