Premarket Approval (PMA)

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.

• Device: Magtrace and Sentimag Magnetic Locatization System (PUV)
• Generic Name: Lymph node location system during sentinel biopsy procedure
• Applicant: Endomagnetics Ltd.,; 330 Cambridge Science Park Milton Rd.; Cambridge CB4 0WN
• PMA Number: P160053
• Supplement Number: S010
• Date Received: 05/14/2024
• Decision Date: 06/07/2024
• Product Code: PUV
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for the post-approval study 1 ml Magtrace w Sentimag PAS.