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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 NumberS005
Date Received03/24/2022
Decision Date09/13/2022
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  
Approved for using new Gen 3 and Gen 3T Sentimag detectors to detect Magtrace, addition of CIDEX OPA as a high level disinfectant for disinfecting Sentimag Gen 3 and Gen 3T detectors, and addition of certain low temperature sterilization systems for certain cycles for sterilization of Sentimag Gen 3 and Gen 3T detectors.
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