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ALAIR BRONCHIAL THERMOPLASTY SYSTEM

FDA premarket approval P080032/S010 · decided 2012-11-09

Approval details

PMA number
P080032
Supplement
S010
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
ALAIR BRONCHIAL THERMOPLASTY SYSTEM
Generic name
Bronchial thermoplasty system
Applicant
Boston Scientific Corp
Date received
2012-10-11
Decision date
2012-11-09
Days to decision
29 days
Decision code
APPR
Product code
OOY
Advisory committee
Anesthesiology
Expedited review
No
Location
Sunnyvale, CA
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.

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510(k) clearances by this applicant

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WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853)Boston Scientific Corp2015-11-20
AXIOS Stent with Electrocautery Enhanced Delivery System (K150692)Boston Scientific Corp2015-08-05
XXL Vascular Balloon Dilatation Catheter (K150303)Boston Scientific Corp2015-06-15
Chariot Guiding Sheath (K150186)Boston Scientific Corp2015-06-05
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679)Boston Scientific Corp2015-05-29
JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820)Boston Scientific Corp2014-10-21