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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 NumberS004
Date Received04/01/2021
Decision Date09/20/2021
Product Code PUV 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for site located at 305 Ashcake Road, Suite L, Ashland, Virginia 23005 USA
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