Atlas FDA

Alair Bronchial Thermoplasty System

FDA premarket approval P080032/S020 · decided 2021-11-26

Approval details

PMA number
P080032
Supplement
S020
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Alair Bronchial Thermoplasty System
Generic name
Bronchial thermoplasty system
Applicant
Boston Scientific Corp
Date received
2021-10-28
Decision date
2021-11-26
Days to decision
29 days
Decision code
OK30
Product code
OOY
Advisory committee
Anesthesiology
Expedited review
No
Location
Sunnyvale, CA
Statement
Rotablator Rotational Angioplasty System, ROTAPRO Rotational Atherectomy System and the Alair Bronchial Thermoplasty System is approved for the addition of automated ultrasonic cleaning equipment with forced air dryer at the supplier for components used in the Rotalink and ROTAPRO Advancers and Alair Catheter.

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