ALAIR BRONCHIAL THERMOPLASTY SYSTEM
FDA premarket approval P080032/S012 · decided 2013-07-03
Approval details
- PMA number
- P080032
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ALAIR BRONCHIAL THERMOPLASTY SYSTEM
- Generic name
- Bronchial thermoplasty system
- Applicant
- Boston Scientific Corp
- Date received
- 2012-12-26
- Decision date
- 2013-07-03
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- OOY
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Sunnyvale, CA
- 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 FACILIT
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