MARGINPROBE SYSTEM
FDA premarket approval P110014/S003 · decided 2014-09-24
Approval details
- PMA number
- P110014
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MARGINPROBE SYSTEM
- Generic name
- Diagnostic low electric field
- Applicant
- Dilon Medical Technologies, Ltd.
- Date received
- 2014-04-15
- Decision date
- 2014-09-24
- Days to decision
- 162 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 MADE TO THE MARGINPROBE CONSOLE FROMMARGINPROBE TYPE 1.1 TO MARGINPROBE TYPE 1.2.
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