PMA P160053S002

Device: MagtraceTM and Sentimag(R) Magnetic Locatization System
Applicant: Endomagnetics Ltd.,
Product code: PUV
Decision date: 2022-12-06
Generic name: Lymph node location system during sentinel biopsy procedure
Approval order statement: Approved 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. For patients undergoing lumpectomy, nipple sparing, nipple areolar sparing or skin sparing procedures, Magtrace is indicated to be injected only peritumorally.

Current openFDA PMA Record#

Device: MagtraceTM and Sentimag(R) Magnetic Locatization System
Applicant: Endomagnetics Ltd.,
PMA number: P160053
Supplement: S002
Product code: PUV
Generic name: Lymph node location system during sentinel biopsy procedure
Decision date: 2022-12-06
Decision code: APPR
Date received: 2018-08-30
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approved 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. For patients undergoing lumpectomy, nipple sparing, nipple areolar sparing or skin sparing procedures, Magtrace is indicated to be injected only peritumorally.