PMA
P130018: PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN
FDA PMA · Device, incontinence, mechanical/hydraulic · Uromedica, Inc.
Key facts
| PMA number | P130018 |
|---|---|
| Trade name | PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN |
| Generic name | Device, incontinence, mechanical/hydraulic |
| Applicant | Uromedica, Inc. |
| Owner/operator | UROMEDICA, INC. |
| Product code | EZY |
| Approval date | Nov 24, 2015 |
| Docket number | 15M-4473 |
| Notice date | Feb 27, 2017 |
| Establishment registration | 3003477176 |
| FEI number | 3003477176 |
At a glance
- 1–9 Supplements
- Feb 11, 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- No Withdrawn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: