PMA P080032S012

Device: ALAIR BRONCHIAL THERMOPLASTY SYSTEM
Applicant: Boston Scientific Corp
PMA number: P080032
Supplement: S012
Product code: OOY
Decision date: 2013-07-03
Classification: Bronchial Thermoplasty System
Generic name: Bronchial thermoplasty system
Approval order 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.

Current openFDA PMA Record#

Device: ALAIR BRONCHIAL THERMOPLASTY SYSTEM
Applicant: Boston Scientific Corp
PMA number: P080032
Supplement: S012
Product code: OOY
Generic name: Bronchial thermoplasty system
Decision date: 2013-07-03
Decision code: APPR
Date received: 2012-12-26
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.