PMA P080032S004

Device: ALAIR BRONCHIAL THERMOPLASTY SYSTEM
Applicant: Boston Scientific Corp
PMA number: P080032
Supplement: S004
Product code: OOY
Decision date: 2011-02-04
Classification: Bronchial Thermoplasty System
Generic name: Bronchial thermoplasty system
Approval order statement: APPROVAL FOR ADDING GAMMA IRRADIATION AS AN ALTERNATIVE STERILIZATION METHOD, ESTABLISHING EXPIRATION DATING FOR THAT STERILIZATION METHOD, AND ADDING STERIGENICS (HAYWARD, CALIFORNIA) AS A CONTRACT STERILIZER.

Current openFDA PMA Record#

Device: ALAIR BRONCHIAL THERMOPLASTY SYSTEM
Applicant: Boston Scientific Corp
PMA number: P080032
Supplement: S004
Product code: OOY
Generic name: Bronchial thermoplasty system
Decision date: 2011-02-04
Decision code: APPR
Date received: 2010-08-13
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR ADDING GAMMA IRRADIATION AS AN ALTERNATIVE STERILIZATION METHOD, ESTABLISHING EXPIRATION DATING FOR THAT STERILIZATION METHOD, AND ADDING STERIGENICS (HAYWARD, CALIFORNIA) AS A CONTRACT STERILIZER.