# P080032: Alair Bronchial Thermoplasty System

- Pathway: PMA
- Applicant: Boston Scientific Corp
- Decided: Apr 27, 2010 after 483 days
- Product code: OOY (Bronchial Thermoplasty System)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- May 28, 2013 · Class II · Z-1748-2013: Boston Scientific has discovered an inconsistent "Use By" expiration date on a single lot/batch of Alair Bronchial Thermoplasty Catheters. The expiration date indicated on the inner tray, 2012-04, is 

Source page: https://510kreport.com/device/P080032
Methodology: https://510kreport.com/methodology