MagtraceTM and Sentimag(R) Magnetic Locatization System

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Premarket Approval P160053 S001

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.

Pre-market Approval Supplement Details

Approval for packaging magtrace vials with new replacement stoppers (i. E. , west 1358).

• 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: 2018-07-30
• Decision Date: 2019-05-08
• PMA: P160053
• Supplement: S001
• Product Code: PUV
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: ENDOMAGNETICS LTD. the Jeffreys Building, Cowley Road cambridge CB4 O

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