PMA
P230044: alfapump System
FDA PMA · Alfapump System · Sequana Medical NV
Key facts
| PMA number | P230044 |
|---|---|
| Trade name | alfapump System |
| Generic name | Alfapump System |
| Applicant | Sequana Medical NV |
| Product code | SDQ |
| Approval date | Dec 20, 2024 |
| Docket number | 25M-0050 |
| Notice date | Jan 10, 2025 |
At a glance
- 1–9 Supplements
- May 5, 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- No Withdrawn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: