Bronchial Thermoplasty System
Basic Information
- Device Name
- Bronchial Thermoplasty System
- Trade Name
- ALAIR BRONCHIAL THERMOPLASTY SYSTEM
- PMA Number
- P080032
- Supplement Number
- S012
- 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
- July 3, 2013
- Date Received
- December 26, 2012
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR 1) THE MANUFACTURING TRANSFER OF THE ALAIR CATHETER FROM THE CURRENT FACILITY IN SUNNYVALE, CALIFORNIA, TO THE BOSTON SCIENTIFIC FACILITY IN CORK, IRELAND; AND 2) THE QUALIFICATION OF SYNERGY HEALTH IRELAND LTD, LOCATED IN TULLAMORE, IRELAND, AS A STERILIZATION SITE FOR THE ALAIR CATHETER, AND MINOR DESIGN CHANGES TO THE ALAIR CATHETER.APPROVAL FOR 1) THE MANUFACTURING TRANSFER OF THE ALAIR CATHETER FROM THE CURRENT FACILITY IN SUNNYVALE, CALIFORNIA, TO THE BOSTON SCIENTIFIC FACILITY IN CORK, IRELAND; AND 2) THE QUALIFICATION OF SYNERGY HEALTH IRELAND LTD, LOCATED IN TULLAMORE, IRELAND, AS A STERILIZATION SITE FOR THE ALAIR CATHETER, AND MINOR DESIGN CHANGES TO THE ALAIR CATHETER.
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 |