PMA
P110014: DUNE MEDICAL DEVICES MARGINPROBE SYSTEM
FDA PMA · Diagnostic low electric field · Dilon Medical Technologies, Ltd.
Key facts
| PMA number | P110014 |
|---|---|
| Trade name | DUNE MEDICAL DEVICES MARGINPROBE SYSTEM |
| Generic name | Diagnostic low electric field |
| Applicant | Dilon Medical Technologies, Ltd. |
| Owner/operator | Dilon Medical Technologies, Inc |
| Product code | OEE |
| Approval date | Dec 27, 2012 |
| Docket number | 13M-0036 |
| Notice date | Jan 8, 2012 |
| Establishment registration | 3005755031 |
| FEI number | 3005755031 |
At a glance
- 10–99 Supplements
- Sep 17, 2025 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- No Withdrawn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: