|
Device | ALAIR BRONCHIAL THERMOPLASTY SYSTEM |
Generic Name | Bronchial thermoplasty system |
Applicant | Boston Scientific Corp. 888 ROSS DRIVE SUITE 100 SUNNYVALE, CA 94089 |
PMA Number | P080032 |
Supplement Number | S016 |
Date Received | 06/01/2015 |
Decision Date | 12/29/2015 |
Product Code |
OOY |
Advisory Committee |
Anesthesiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR DESIGN CHANGE TO THE ALAIR RF CONTROLLER TO REPLACE AN OBSOLETE COMPONENT THAT IS NO LONGER COMMERCIALLY AVAILABLE. |