|
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 | S019 |
Date Received | 08/24/2021 |
Decision Date | 02/18/2022 |
Product Code |
OOY |
Advisory Committee |
Anesthesiology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for updating the labeling to include the results of the post approval study RESCUE 3. |