MarginProbe System
FDA premarket approval P110014/S009 · decided 2019-09-20
Approval details
- PMA number
- P110014
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- MarginProbe System
- Generic name
- Diagnostic low electric field
- Applicant
- Dilon Medical Technologies, Ltd.
- Date received
- 2019-08-29
- Decision date
- 2019-09-20
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- OEE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Business Park-South 3088900
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
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