PMA P080032S015
- Device
- ALAIR BRONCHIAL THERMOPLASTY RADIOFREQUENCY CONTROLLER
- Applicant
- Boston Scientific Corp
- PMA number
- P080032
- Supplement
- S015
- Product code
- OOY
- Decision date
- 2014-06-17
- Classification
- Bronchial Thermoplasty System
- Generic name
- Bronchial thermoplasty system
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT STELLARTECH RESEARCH CORPORATION, IN MILPITAS, CALIFORNIA.
Current openFDA PMA Record#
- Device
- ALAIR BRONCHIAL THERMOPLASTY RADIOFREQUENCY CONTROLLER
- Applicant
- Boston Scientific Corp
- PMA number
- P080032
- Supplement
- S015
- Product code
- OOY
- Generic name
- Bronchial thermoplasty system
- Decision date
- 2014-06-17
- Decision code
- APPR
- Date received
- 2014-03-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT STELLARTECH RESEARCH CORPORATION, IN MILPITAS, CALIFORNIA.