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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 NumberS012
Date Received12/26/2012
Decision Date07/03/2013
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 1) THE MANUFACTURING TRANSFER OF THE ALAIR CATHETER FROM THE CURRENT FACILITY IN SUNNYVALE, CALIFORNIA, TO THE BOSTON SCIENTIFIC FACILITY IN CORK, IRELAND; AND 2) THE QUALIFICATION OF SYNERGY HEALTH IRELAND LTD, LOCATED IN TULLAMORE, IRELAND, AS A STERILIZATION SITE FOR THE ALAIR CATHETER, AND MINOR DESIGN CHANGES TO THE ALAIR CATHETER.APPROVAL FOR 1) THE MANUFACTURING TRANSFER OF THE ALAIR CATHETER FROM THE CURRENT FACILITY IN SUNNYVALE, CALIFORNIA, TO THE BOSTON SCIENTIFIC FACILITY IN CORK, IRELAND; AND 2) THE QUALIFICATION OF SYNERGY HEALTH IRELAND LTD, LOCATED IN TULLAMORE, IRELAND, AS A STERILIZATION SITE FOR THE ALAIR CATHETER, AND MINOR DESIGN CHANGES TO THE ALAIR CATHETER.
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