|
Device | Alair Bronchial Thermoplasty Catheter |
Generic Name | Bronchial thermoplasty system |
Applicant | Boston Scientific Corp. 888 ROSS DRIVE SUITE 100 SUNNYVALE, CA 94089 |
PMA Number | P080032 |
Supplement Number | S017 |
Date Received | 11/29/2017 |
Decision Date | 10/05/2018 |
Product Code |
OOY |
Advisory Committee |
Anesthesiology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for revising the manufacturing procedure for the Alair Bronchial Thermoplasty Catheter by allowing rework of the polyester heat shrink insulation placed over the electrodes if inspection criteria are not met. |