MARGINPROBE SYSTEM
FDA premarket approval P110014/S006 · decided 2016-03-14
Approval details
- PMA number
- P110014
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MARGINPROBE SYSTEM
- Generic name
- Diagnostic low electric field
- Applicant
- Dilon Medical Technologies, Ltd.
- Date received
- 2015-07-06
- Decision date
- 2016-03-14
- Days to decision
- 252 days
- Decision code
- APPR
- Product code
- OEE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Business Park-South 3088900
- Statement
- Approval for changes to the console in order to make the console compliant with the European Commission Restriction of the use of certain hazardous substances (RoHS) directive requirements.
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