PMA
P250007: Zenflow Spring® Implant and Delivery System
FDA PMA · STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT · Zenflow, Inc.
Key facts
| PMA number | P250007 |
|---|---|
| Trade name | Zenflow Spring® Implant and Delivery System |
| Generic name | STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT |
| Applicant | Zenflow, Inc. |
| Owner/operator | Zenflow, Inc. |
| Product code | MER |
| Approval date | Dec 11, 2025 |
| Docket number | FDA-7228 |
| Notice date | Dec 19, 2025 |
| Establishment registration | 3014211785 |
| FEI number | 3014211785 |
At a glance
- None Supplements
- Dec 11, 2025 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- No Withdrawn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: