MagtraceTM and Sentimag(R) Magnetic Locatization System

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Premarket Approval P160053 S003

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

Storing the subject product at a new storage site in endomagnetics ltd. In cambridge, united kingdom.

• 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: 2018-11-26
• Decision Date: 2018-12-28
• PMA: P160053
• Supplement: S003
• Product Code: PUV
• Docket Number: Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia
• Advisory Committee: General & Plastic Surgery
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• 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