Magtrace/and Sentimag Magnetic Localization System

FDA Premarket Approval P160053 S004

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 site located at 305 ashcake road, suite l, ashland, virginia 23005 usa

DeviceMagtrace/and Sentimag Magnetic Localization System
Generic NameLymph Node Location System During Sentinel Biopsy Procedure
ApplicantENDOMAGNETICS LTD.
Date Received2021-04-01
Decision Date2021-09-20
PMAP160053
SupplementS004
Product CodePUV 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address ENDOMAGNETICS LTD. the Jeffreys Building, Cowley Road cambridge CB4 O

Supplemental Filings

Supplement NumberDateSupplement Type
P160053Original Filing
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

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