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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
PMA NumberP080032
Supplement NumberS004
Date Received08/13/2010
Decision Date02/04/2011
Product Code
OOY[ Registered Establishments with OOY ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding gamma irradiation as an alternative sterilization method, establishing expiration dating for that sterilization method, and adding sterigenics (hayward, california) as a contract sterilizer.