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Device | MagtraceTM and Sentimag(R) Magnetic Locatization System |
Generic Name | Lymph node location system during sentinel biopsy procedure |
Applicant | ENDOMAGNETICS LTD. 330 Cambridge Science Park, Milton Road Cambridge CB4 0 |
PMA Number | P160053 |
Date Received | 11/30/2016 |
Decision Date | 07/24/2018 |
Product Code |
PUV |
Docket Number | 18M-2887 |
Notice Date | 06/29/2018 |
Advisory Committee |
General & Plastic Surgery |
Clinical Trials | NCT02336737
|
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the MagtraceTM and Sentimag® Magnetic Localization System. The MagtraceTM and Sentimag® Magnetic Localization System is indicated 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. MagtraceTM is intended and calibrated for use ONLY with the Sentimag® system. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Supplements: |
S001 S002 S003 S004 S005 S007 S009 |