ALAIR BRONCHIAL THERMOPLASTY SYSTEM
FDA premarket approval P080032/S011 · decided 2012-12-11
Approval details
- PMA number
- P080032
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ALAIR BRONCHIAL THERMOPLASTY SYSTEM
- Generic name
- Bronchial thermoplasty system
- Applicant
- Boston Scientific Corp
- Date received
- 2012-11-15
- Decision date
- 2012-12-11
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- OOY
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Sunnyvale, CA
- Statement
- IMPLEMENTATION OF CHANGE RELATED TO THE STERILIZATION OF THE CATHETER WHICH IS USED WITH THE DEVICE.
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