PMA P080032S010

Device: ALAIR BRONCHIAL THERMOPLASTY SYSTEM
Applicant: Boston Scientific Corp
PMA number: P080032
Supplement: S010
Product code: OOY
Decision date: 2012-11-09
Classification: Bronchial Thermoplasty System
Generic name: Bronchial thermoplasty system
Approval order statement: APPROVAL FOR LABELING CHANGES TO THE ALAIR CATHETER MODEL ATS 2-5 DIRECTIONS FOR USE (DFU), ALAIR RADIOFREQUENCY (RF) CONTROLLER MODEL ATS 200 OPERATOR'S MANUAL, AND ALAIR BRONCHIAL THERMOPLASTY SYSTEM PATIENT BROCHURE.

Current openFDA PMA Record#

Device: ALAIR BRONCHIAL THERMOPLASTY SYSTEM
Applicant: Boston Scientific Corp
PMA number: P080032
Supplement: S010
Product code: OOY
Generic name: Bronchial thermoplasty system
Decision date: 2012-11-09
Decision code: APPR
Date received: 2012-10-11
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING CHANGES TO THE ALAIR CATHETER MODEL ATS 2-5 DIRECTIONS FOR USE (DFU), ALAIR RADIOFREQUENCY (RF) CONTROLLER MODEL ATS 200 OPERATOR'S MANUAL, AND ALAIR BRONCHIAL THERMOPLASTY SYSTEM PATIENT BROCHURE.