PMA
P190006: Axonics Sacral Neuromodulation System
FDA PMA · Implanted electrical device intended for treatment of fecal incontinence · Boston Scientific Corporation
Key facts
| PMA number | P190006 |
|---|---|
| Trade name | Axonics Sacral Neuromodulation System |
| Generic name | Implanted electrical device intended for treatment of fecal incontinence |
| Applicant | Boston Scientific Corporation |
| Owner/operator | Boston Scientific Corporation |
| Product code | QON |
| Approval date | Sep 6, 2019 |
| Docket number | 19M-4186 |
| Notice date | Sep 30, 2019 |
| Establishment registration | 3002968685 |
At a glance
- 100–999 Supplements
- Aug 7, 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- No Withdrawn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: