PMA
P180002: Zephyr Endobronchial Valve System
FDA PMA · Valve, pulmonary · Pulmonx Corporation
Key facts
| PMA number | P180002 |
|---|---|
| Trade name | Zephyr Endobronchial Valve System |
| Generic name | Valve, pulmonary |
| Applicant | Pulmonx Corporation |
| Owner/operator | Pulmonx, Corp. |
| Product code | NJK |
| Approval date | Jun 29, 2018 |
| Docket number | 18M-2571 |
| Notice date | Jun 29, 2018 |
| Establishment registration | 3007797756 |
| FEI number | 3007797756 |
At a glance
- 10–99 Supplements
- Sep 11, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: