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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namediagnostic low electric field
Generic Namediagnostic low electric field
111 speen st suite 101
framingham, MA 01701
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
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 StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007