PMA P160053S009

Device: Magtrace and Sentimag Magnetic Localization System
Applicant: Endomagnetics Ltd.,
Product code: PUV
Decision date: 2024-04-15
Generic name: Lymph node location system during sentinel biopsy procedure
Approval order statement: using a new dose (1 ml) of Magtrace with Sentimag® Magnetic Localization System 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 or lumpectomy

Current openFDA PMA Record

Device: Magtrace and Sentimag Magnetic Localization System
Applicant: Endomagnetics Ltd.,
PMA number: P160053
Supplement: S009
Product code: PUV
Generic name: Lymph node location system during sentinel biopsy procedure
Decision date: 2024-04-15
Decision code: APPR
Date received: 2023-06-12
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: using a new dose (1 ml) of Magtrace with Sentimag® Magnetic Localization System 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 or lumpectomy