PMA
P250011: ProVee System for BPH
FDA PMA · STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT · Proverum, Ltd.
Key facts
| PMA number | P250011 |
|---|---|
| Trade name | ProVee System for BPH |
| Generic name | STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT |
| Applicant | Proverum, Ltd. |
| Owner/operator | ProVerum Limited |
| Product code | MER |
| Approval date | Dec 9, 2025 |
| Establishment registration | 3017896224 |
| FEI number | 3017896224 |
At a glance
- 1–9 Supplements
- Sep 24, 2026 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- No Withdrawn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: