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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 NumberS007
Date Received06/03/2011
Decision Date06/21/2011
Product Code
OOY[ Registered Establishments with OOY ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post approval study protocol.
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