FDA.reportPublic FDA data

PMA P080032S020

Device
Alair Bronchial Thermoplasty System
Applicant
Boston Scientific Corp
PMA number
P080032
Supplement
S020
Product code
OOY
Decision date
2021-11-26
Generic name
Bronchial thermoplasty system
Approval order 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.

Current openFDA PMA Record#

Device
Alair Bronchial Thermoplasty System
Applicant
Boston Scientific Corp
PMA number
P080032
Supplement
S020
Product code
OOY
Generic name
Bronchial thermoplasty system
Decision date
2021-11-26
Decision code
OK30
Date received
2021-10-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.