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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMagtraceTM and Sentimag(R) Magnetic Locatization System
Generic NameLymph node location system during sentinel biopsy procedure
ApplicantENDOMAGNETICS LTD.
330 Cambridge Science Park, Milton Road
Cambridge CB4 0
PMA NumberP160053
Supplement NumberS002
Date Received08/30/2018
Decision Date12/06/2022
Product Code PUV 
Docket Number 22M-3128
Notice Date 12/08/2022
Advisory Committee General & Plastic Surgery
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approved 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 or lumpectomy. For patients undergoing lumpectomy, nipple sparing, nipple areolar sparing or skin sparing procedures, Magtrace is indicated to be injected only peritumorally.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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