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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 NumberS005
Date Received11/08/2010
Decision Date06/10/2011
Product Code OOY 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT ASTHMATX, INC. IN SUNNYVALE, CALIFORNIA.
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