PMA
P080025: MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM
FDA PMA · Implanted electrical device intended for treatment of fecal incontinence · Medtronic Neuromodulation
Key facts
| PMA number | P080025 |
|---|---|
| Trade name | MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM |
| Generic name | Implanted electrical device intended for treatment of fecal incontinence |
| Applicant | Medtronic Neuromodulation |
| Owner/operator | Medtronic, Inc. |
| Product code | QON |
| Approval date | Mar 14, 2011 |
| Docket number | 11M-0175 |
| Notice date | Mar 31, 2011 |
| Establishment registration | 2182207 |
| FEI number | 2182207 |
At a glance
- 100–999 Supplements
- Oct 9, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: