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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.
 
DeviceMagtrace and Sentimag Magnetic Localization System
Generic NameLymph node location system during sentinel biopsy procedure
ApplicantEndomagnetics Ltd.,
330 Cambridge Science Park Milton Rd.
Cambridge CB4 0WN
PMA NumberP160053
Supplement NumberS009
Date Received06/12/2023
Decision Date04/15/2024
Product Code PUV 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
using a new dose (1 ml) of Magtrace with Sentimag® Magnetic Localization System 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
Post-Approval StudyShow Report Schedule and Study Progress
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