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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameDUNE MEDICAL DEVICES MARGINPROBE SYSTEM
Classification Namediagnostic low electric field
ApplicantDUNE MEDICAL DEVICES INC
PMA NumberP110014
Date Received04/04/2011
Decision Date12/27/2012
Product Code
OEE[ Registered Establishments with 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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Post-Approval StudyShow Report Schedule and Study Progress
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