FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Bronchial Thermoplasty System
PMA: P080032
·
Supplement: S006
·
Decision Apr 7, 2011
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
- S006
- 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
- April 7, 2011
- Date Received
- February 11, 2011
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol - OSB
- Expedited Review
- N
Advisory Committee Statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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 |