• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
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
ApplicantBOSTONSCIENTIFIC
PMA NumberP080032
Supplement NumberS012
Date Received12/26/2012
Decision Date07/03/2013
Product Code
OOY[ Registered Establishments with OOY ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) the manufacturing transfer of the alair catheter from the current facility in sunnyvale, california, to the boston scientific facility in cork, ireland; and 2) the qualification of synergy health ireland ltd, located in tullamore, ireland, as a sterilization site for the alair catheter, and minor design changes to the alair catheter. Approval for 1) the manufacturing transfer of the alair catheter from the current facility in sunnyvale, california, to the boston scientific facility in cork, ireland; and 2) the qualification of synergy health ireland ltd, located in tullamore, ireland, as a sterilization site for the alair catheter, and minor design changes to the alair catheter.
-
-