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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.
 
DeviceMagtraceTM and Sentimag(R) Magnetic Locatization System
Generic NameLymph node location system during sentinel biopsy procedure
ApplicantEndomagnetics Ltd.,
330 Cambridge Science Park Milton Rd.
Cambridge CB4 0
PMA NumberP160053
Date Received11/30/2016
Decision Date07/24/2018
Product Code PUV 
Docket Number 18M-2887
Notice Date 06/29/2018
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT02336737
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the MagtraceTM and Sentimag® Magnetic Localization System. The MagtraceTM and Sentimag® Magnetic Localization System is indicated to assist in localizing lymph nodes draining a tumor site, as part of a sentinel lymph node biopsy procedure, in patients with breast cancer undergoing a mastectomy. MagtraceTM is intended and calibrated for use ONLY with the Sentimag® system.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S002 S003 S004 S005 S007 S009 S010 S011 
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