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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 Rd.
Cambridge CB4 0WN
PMA NumberP160053
Supplement NumberS001
Date Received07/30/2018
Decision Date05/08/2019
Product Code PUV 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for packaging Magtrace vials with new replacement stoppers (i.e., West 1358).
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