|
Device | DUNE MEDICAL DEVICES MARGINPROBE SYSTEM |
Generic Name | Diagnostic low electric field |
Applicant | Dilon Medical Technologies, Ltd. 20 Alon Hatavor Street P.O. Box 3131 Business Park-South 3088900 |
PMA Number | P110014 |
Date Received | 04/04/2011 |
Decision Date | 12/27/2012 |
Product Code |
OEE |
Docket Number | 13M-0036 |
Notice Date | 01/08/2012 |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials | NCT00749931
|
Expedited Review Granted? | Yes |
Combination Product | No |
Approval Order 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 |