PMA P080032S011
- Device
- ALAIR BRONCHIAL THERMOPLASTY SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P080032
- Supplement
- S011
- Product code
- OOY
- Decision date
- 2012-12-11
- Classification
- Bronchial Thermoplasty System
- Generic name
- Bronchial thermoplasty system
- Approval order statement
- IMPLEMENTATION OF CHANGE RELATED TO THE STERILIZATION OF THE CATHETER WHICH IS USED WITH THE DEVICE.
Current openFDA PMA Record#
- Device
- ALAIR BRONCHIAL THERMOPLASTY SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P080032
- Supplement
- S011
- Product code
- OOY
- Generic name
- Bronchial thermoplasty system
- Decision date
- 2012-12-11
- Decision code
- OK30
- Date received
- 2012-11-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF CHANGE RELATED TO THE STERILIZATION OF THE CATHETER WHICH IS USED WITH THE DEVICE.