MagtraceTM and Sentimag(R) Magnetic Locatization System

FDA Premarket Approval P160053 S005

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

DeviceMagtraceTM and Sentimag(R) Magnetic Locatization System
Generic NameLymph Node Location System During Sentinel Biopsy Procedure
ApplicantENDOMAGNETICS LTD.330 Cambridge Science Park, Milton Roadcambridge CB4 0 PMA NumberP160053 Supplement NumberS005 Date Received03/24/2022 Decision Date09/13/2022 Product Code PUV  Advisory Committee General & Plastic Surgery Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-03-24
Decision Date2022-09-13
PMAP160053
SupplementS005
Product CodePUV 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductYes
Applicant AddressENDOMAGNETICS LTD.
330 Cambridge Science Park, Milton Road
cambridge CB4 0 PMA NumberP160053 Supplement NumberS005 Date Received03/24/2022 Decision Date09/13/2022 Product Code PUV  Advisory Committee General & Plastic Surgery Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductYes Approval Order Statement  
Approved For Using New Gen 3 And Gen 3T Sentimag Detectors To Detect Magtrace, Addition Of CIDEX OPA As A High Level Disinfectant For Disinfecting Sentimag Gen 3 And Gen 3T Detectors, And Addition Of Certain Low Temperature Sterilization Systems For Certain Cycles For Sterilization Of Sentimag Gen 3 And Gen 3T Detectors.

Supplemental Filings

Supplement NumberDateSupplement Type
P160053Original 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

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