MarginProbe System
FDA premarket approval P110014/S012 · decided 2022-04-06
Approval details
- PMA number
- P110014
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- MarginProbe System
- Generic name
- Diagnostic low electric field
- Applicant
- Dilon Medical Technologies, Ltd.
- Date received
- 2021-10-14
- Decision date
- 2022-04-06
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- OEE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Business Park-South 3088900
- Statement
- Approval for labeling changes including post-approval study clinical data
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