|
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 | S018 |
Date Received | 04/30/2021 |
Decision Date | 05/27/2021 |
Product Code |
OOY |
Advisory Committee |
Anesthesiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Replacing components of an extrusion line. |