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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 NumberS004
Date Received08/13/2010
Decision Date02/04/2011
Product Code OOY 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDING GAMMA IRRADIATION AS AN ALTERNATIVE STERILIZATION METHOD, ESTABLISHING EXPIRATION DATING FOR THAT STERILIZATION METHOD, AND ADDING STERIGENICS (HAYWARD, CALIFORNIA) AS A CONTRACT STERILIZER.
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