PMA
P240036: OmniaSecure™ MRI SureScan™ Lead Model 3930M
FDA PMA · Permanent defibrillator electrodes · Medtronic, Inc.
Key facts
| PMA number | P240036 |
|---|---|
| Trade name | OmniaSecure™ MRI SureScan™ Lead Model 3930M |
| Generic name | Permanent defibrillator electrodes |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | NVY |
| Approval date | Apr 22, 2025 |
| Docket number | 25M-1116 |
| Notice date | Apr 30, 2025 |
| Establishment registration | 2182208 |
| FEI number | 2182208 |
At a glance
- 1–9 Supplements
- Apr 24, 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- No Withdrawn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: