PMA
P240011: Medtronic Altaviva System
FDA PMA · Stimulator, tibial, electrical, implantable, for urinary incontinence · Medtronic Neuromodulation
Key facts
| PMA number | P240011 |
|---|---|
| Trade name | Medtronic Altaviva System |
| Generic name | Stimulator, tibial, electrical, implantable, for urinary incontinence |
| Applicant | Medtronic Neuromodulation |
| Owner/operator | Medtronic, Inc. |
| Product code | QPT |
| Approval date | Sep 18, 2025 |
| Establishment registration | 2182207 |
| FEI number | 2182207 |
At a glance
- 10–99 Supplements
- Sep 14, 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- No Withdrawn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: