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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceALAIR BRONCHIAL THERMOPLASTY RADIOFREQUENCY CONTROLLER
Classification Namebronchial thermoplasty system
Generic Namebronchial thermoplasty system
Applicant
Boston Scientific Corp.
888 ross drive
suite 100
sunnyvale, CA 94089
PMA NumberP080032
Supplement NumberS015
Date Received03/14/2014
Decision Date06/17/2014
Product Code
OOY[ Registered Establishments with 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 Product No
Approval Order Statement 
Approval for a manufacturing site located at stellartech research corporation, in milpitas, california.
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