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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceDUNE MEDICAL DEVICES MARGINPROBE SYSTEM
Generic NameDiagnostic low electric field
ApplicantDilon Medical Technologies, Ltd.
20 Alon Hatavor Street
P.O. Box 3131
Business Park-South 3088900 
PMA NumberP110014
Date Received04/04/2011
Decision Date12/27/2012
Product Code OEE 
Docket Number 13M-0036
Notice Date 01/08/2012
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT00749931
Expedited Review Granted? Yes
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 
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