DUNE MEDICAL DEVICES MARGINPROBE SYSTEM
FDA premarket approval P110014 · decided 2012-12-27
Approval details
- PMA number
- P110014
- Trade name
- DUNE MEDICAL DEVICES MARGINPROBE SYSTEM
- Generic name
- Diagnostic low electric field
- Applicant
- Dilon Medical Technologies, Ltd.
- Date received
- 2011-04-04
- Decision date
- 2012-12-27
- Days to decision
- 633 days
- Decision code
- APPR
- Product code
- OEE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- Yes
- Location
- Business Park-South 3088900
- Statement
- APPROVAL FOR THE MARGINPROBE SYSTEM. THIS DEVICE IS AN ADJUNCTIVE DIAGNOSTIC TOOL FOR IDENTIFICATION OF CANCEROUS TISSUE AT THE MARGINS (<= 1MM) OF THE MAIN EX-VIVO LUMPECTOMY SPECIMEN FOLLOWING PRIMARY EXCISION AND IS INDICATED FOR INTRAOPERATIVE USE, IN CONJUNCTION WITH STANDARD METHODS (SUCH AS INTRAOPERATIVE IMAGING AND PALPATION) IN PATIENTS UNDERGOING BREAST LUMPECTOMY SURGERY FOR PREVIOUSLY DIAGNOSED BREAST CANCER.
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