PMA
P080032: ALAIR BRONCHIAL THERMOPLASTY SYSTEM
FDA PMA · Bronchial thermoplasty system · Boston Scientific Corp
Key facts
| PMA number | P080032 |
|---|---|
| Trade name | ALAIR BRONCHIAL THERMOPLASTY SYSTEM |
| Generic name | Bronchial thermoplasty system |
| Applicant | Boston Scientific Corp |
| Owner/operator | Boston Scientific Corporation |
| Product code | OOY |
| Approval date | Apr 27, 2010 |
| Docket number | 10M-0242 |
| Notice date | May 19, 2010 |
| Establishment registration | 3005099803 |
| FEI number | 3005099803 |
At a glance
- 10–99 Supplements
- Feb 18, 2022 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: