PMA P080032S005
- Device
- ALAIR BRONCHIAL THERMOPLASTY SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P080032
- Supplement
- S005
- Product code
- OOY
- Decision date
- 2011-06-10
- Classification
- Bronchial Thermoplasty System
- Generic name
- Bronchial thermoplasty system
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ASTHMATX, INC. IN SUNNYVALE, CALIFORNIA.
Current openFDA PMA Record#
- Device
- ALAIR BRONCHIAL THERMOPLASTY SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P080032
- Supplement
- S005
- Product code
- OOY
- Generic name
- Bronchial thermoplasty system
- Decision date
- 2011-06-10
- Decision code
- APPR
- Date received
- 2010-11-08
- 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 ASTHMATX, INC. IN SUNNYVALE, CALIFORNIA.