PMA supplement
P110014 S012: MarginProbe System
FDA PMA supplement · Normal 180 Day Track No User Fee · Dilon Medical Technologies, Ltd.
Key facts
| Original PMA | P110014 |
|---|---|
| Supplement number | S012 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - PAS |
| Trade name | MarginProbe System |
| Generic name | Diagnostic low electric field |
| Applicant | Dilon Medical Technologies, Ltd. |
| Product code | OEE |
| Received date | Oct 14, 2021 |
| Decision date | Apr 6, 2022 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: