PMA supplement
P130018 S005: ProACT™ Adjustable Continence Therapy for Men
FDA PMA supplement · Special (Immediate Track) · Uromedica, Inc.
Key facts
| Original PMA | P130018 |
|---|---|
| Supplement number | S005 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | ProACT™ Adjustable Continence Therapy for Men |
| Generic name | Device, incontinence, mechanical/hydraulic |
| Applicant | Uromedica, Inc. |
| Product code | EZY |
| Received date | Dec 30, 2025 |
| Decision date | Jan 28, 2026 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: