PMA P080032S014
- Device
- ALAIR BRONCHIAL THERMOPLASTY SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P080032
- Supplement
- S014
- Product code
- OOY
- Decision date
- 2013-12-02
- Classification
- Bronchial Thermoplasty System
- Generic name
- Bronchial thermoplasty system
- Approval order statement
- CHANGE TO THE MANUFACTURING OF A CABLE CONNECTOR, THE ADDITION OF ANINSPECTION STEP AND THE ELIMINATION OF A FINAL ACCEPTANCE ACTIVITY.
Current openFDA PMA Record#
- Device
- ALAIR BRONCHIAL THERMOPLASTY SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P080032
- Supplement
- S014
- Product code
- OOY
- Generic name
- Bronchial thermoplasty system
- Decision date
- 2013-12-02
- Decision code
- OK30
- Date received
- 2013-11-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE MANUFACTURING OF A CABLE CONNECTOR, THE ADDITION OF ANINSPECTION STEP AND THE ELIMINATION OF A FINAL ACCEPTANCE ACTIVITY.