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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.
Classification Namebronchial thermoplasty system
Generic Namebronchial thermoplasty system
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.