PMA P080032S019
- Device
- Alair Bronchial Thermoplasty System
- Applicant
- Boston Scientific Corp
- Product code
- OOY
- Decision date
- 2022-02-18
- Generic name
- Bronchial thermoplasty system
- Approval order statement
- Approval for updating the labeling to include the results of the post approval study RESCUE 3.
Current openFDA PMA Record#
- Device
- Alair Bronchial Thermoplasty System
- Applicant
- Boston Scientific Corp
- PMA number
- P080032
- Supplement
- S019
- Product code
- OOY
- Generic name
- Bronchial thermoplasty system
- Decision date
- 2022-02-18
- Decision code
- APPR
- Date received
- 2021-08-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updating the labeling to include the results of the post approval study RESCUE 3.