MarginProbe System
FDA premarket approval P110014/S011 · decided 2020-08-14
Approval details
- PMA number
- P110014
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MarginProbe System
- Generic name
- Diagnostic low electric field
- Applicant
- Dilon Medical Technologies, Ltd.
- Date received
- 2020-07-28
- Decision date
- 2020-08-14
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- OEE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Business Park-South 3088900
- Statement
- Changes to device and instructions for use labeling reflecting change in ownership and removal of CE mark.
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