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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.
 
Trade NameALAIR BRONCHIAL THERMOPLASTY SYSTEM
Classification Namebronchial thermoplasty system
ApplicantASTHMATX, INC.
PMA NumberP080032
Supplement NumberS008
Date Received02/21/2012
Decision Date03/22/2012
Product Code
OOY[ Registered Establishments with OOY ]
Advisory Committee Anesthesiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Process changes related to the alair catheter model as well as the alair radiofrequency controller.
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