MagtraceTM and Sentimag(R) Magnetic Locatization System

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Premarket Approval P160053

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

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.

• Device: MagtraceTM and Sentimag(R) Magnetic Locatization System
• Classification Name: Lymph Node Location System During Sentinel Biopsy Procedure
• Generic Name: Lymph Node Location System During Sentinel Biopsy Procedure
• Applicant: ENDOMAGNETICS LTD.
• Date Received: 2016-11-30
• Decision Date: 2018-07-24
• Notice Date: 2018-06-29
• PMA: P160053
• Supplement: S
• Product Code: PUV
• Docket Number: 18M-2887
• Advisory Committee: General & Plastic Surgery
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: ENDOMAGNETICS LTD. the Jeffreys Building, Cowley Road cambridge CB4 O
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling Labeling Part 2
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P160053		Original Filing
S005	2022-03-24	Normal 180 Day Track
S004	2021-04-01	Normal 180 Day Track No User Fee
S003	2018-11-26	30-day Notice
S002
S001	2018-07-30	Real-time Process

NIH GUDID Devices

Device ID	PMA	Supp
15060391210244	P160053	000