PMA
P170001: VIRTIS SACRAL NEUROMODULATION SYSTEM
FDA PMA · Stimulator, electrical, implantable, for incontinence · Cirtec Medical Corporation
Key facts
| PMA number | P170001 |
|---|---|
| Trade name | VIRTIS SACRAL NEUROMODULATION SYSTEM |
| Generic name | Stimulator, electrical, implantable, for incontinence |
| Applicant | Cirtec Medical Corporation |
| Owner/operator | Cirtec Medical Corporation |
| Product code | EZW |
| Approval date | Jan 11, 2023 |
| Establishment registration | 3013368220 |
| FEI number | 3013368220 |
At a glance
- None Supplements
- Jan 11, 2023 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: