Atlas FDA

Alair Bronchial Thermoplasty Catheter

FDA premarket approval P080032/S017 · decided 2018-10-05

Approval details

PMA number
P080032
Supplement
S017
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Alair Bronchial Thermoplasty Catheter
Generic name
Bronchial thermoplasty system
Applicant
Boston Scientific Corp
Date received
2017-11-29
Decision date
2018-10-05
Days to decision
310 days
Decision code
APPR
Product code
OOY
Advisory committee
Anesthesiology
Expedited review
No
Location
Sunnyvale, CA
Statement
Approval for revising the manufacturing procedure for the Alair Bronchial Thermoplasty Catheter by allowing rework of the polyester heat shrink insulation placed over the electrodes if inspection criteria are not met.

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