FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Bronchial Thermoplasty System
PMA: P080032
·
Supplement: S018
·
Decision May 27, 2021
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
- S018
- Device Class
- FDA Class 3
- Product Code
- OOY
- Generic Name
- Bronchial thermoplasty system
- Medical Specialty
- Unknown
- Advisory Committee
- Anesthesiology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- May 27, 2021
- Date Received
- April 30, 2021
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Replacing components of an extrusion line.
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 |