PMA P080032S016
- Device
- ALAIR BRONCHIAL THERMOPLASTY SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P080032
- Supplement
- S016
- Product code
- OOY
- Decision date
- 2015-12-29
- Classification
- Bronchial Thermoplasty System
- Generic name
- Bronchial thermoplasty system
- Approval order statement
- APPROVAL FOR DESIGN CHANGE TO THE ALAIR RF CONTROLLER TO REPLACE AN OBSOLETE COMPONENT THAT IS NO LONGER COMMERCIALLY AVAILABLE.
Current openFDA PMA Record#
- Device
- ALAIR BRONCHIAL THERMOPLASTY SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P080032
- Supplement
- S016
- Product code
- OOY
- Generic name
- Bronchial thermoplasty system
- Decision date
- 2015-12-29
- Decision code
- APPR
- Date received
- 2015-06-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR DESIGN CHANGE TO THE ALAIR RF CONTROLLER TO REPLACE AN OBSOLETE COMPONENT THAT IS NO LONGER COMMERCIALLY AVAILABLE.