MarginProbe
FDA premarket approval P110014/S013 · decided 2025-09-17
Approval details
- PMA number
- P110014
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MarginProbe
- Generic name
- Diagnostic low electric field
- Applicant
- Dilon Medical Technologies, Ltd.
- Date received
- 2025-01-22
- Decision date
- 2025-09-17
- Days to decision
- 238 days
- Decision code
- APPR
- Product code
- OEE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Business Park-South 3088900
- Statement
- Approval for the modification of the MP 2.0 System including MP 2.0 Console and MP 2.a Probe with the use of multiple array technology with multiple sensors.
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