PMA P080032S018
- Device
- Alair Bronchial Thermoplasty System
- Applicant
- Boston Scientific Corp
- PMA number
- P080032
- Supplement
- S018
- Product code
- OOY
- Decision date
- 2021-05-27
- Generic name
- Bronchial thermoplasty system
- Approval order statement
- Replacing components of an extrusion line.
Current openFDA PMA Record#
- Device
- Alair Bronchial Thermoplasty System
- Applicant
- Boston Scientific Corp
- PMA number
- P080032
- Supplement
- S018
- Product code
- OOY
- Generic name
- Bronchial thermoplasty system
- Decision date
- 2021-05-27
- Decision code
- OK30
- Date received
- 2021-04-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacing components of an extrusion line.