FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Bronchial Thermoplasty System
PMA: P080032
·
Supplement: S016
·
Decision Dec 29, 2015
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Bronchial Thermoplasty System
- Trade Name
- ALAIR BRONCHIAL THERMOPLASTY SYSTEM
- PMA Number
- P080032
- Supplement Number
- S016
- Device Class
- FDA Class 3
- Product Code
- OOY
- Generic Name
- Bronchial thermoplasty system
- Medical Specialty
- Unknown
- Advisory Committee
- Anesthesiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 29, 2015
- Date Received
- June 1, 2015
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR DESIGN CHANGE TO THE ALAIR RF CONTROLLER TO REPLACE AN OBSOLETE COMPONENT THAT IS NO LONGER COMMERCIALLY AVAILABLE.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OOY | Bronchial Thermoplasty System | FDA class 3 | Unknown |