PMA
P180007: Spiration® Valve System
FDA PMA · Valve, pulmonary · Gyrus Acmi, Inc.
Key facts
| PMA number | P180007 |
|---|---|
| Trade name | Spiration® Valve System |
| Generic name | Valve, pulmonary |
| Applicant | Gyrus Acmi, Inc. |
| Owner/operator | OLYMPUS CORPORATION |
| Product code | NJK |
| Approval date | Dec 3, 2018 |
| Docket number | 18M-4665 |
| Notice date | Dec 17, 2018 |
| Establishment registration | 3004450998 |
| FEI number | 3004450998 |
At a glance
- 10–99 Supplements
- Aug 20, 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- No Withdrawn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: